{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3050-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;  2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;  3) OB PROCEDURE-LF , Pack Number CDS981335C ;  4) ROBOTIC PACK-LF , Pack Number CDS981757P ;  5) GYN ROBOTIC , Pack Number CDS981826J ;  6) ROBOTIC CDS , Pack Number CDS981882Q ;  7) ROBOTIC CDS , Pack Number CDS981882R ;  8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ;  9) D&C CDS-WRMC, Pack Number CDS982331N ;  10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ;  11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ;  12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ;  13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ;  14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ;  15) GYN/ABDOMINAL , Pack Number CDS982725M ;  16) ROBOTIC CDS , Pack Number CDS982888D ;  17) ROBOTIC CDS , Pack Number CDS982888F ;  18) ROBOTIC CDS , Pack Number CDS982888G ;  19) ROBOTIC CDS , Pack Number CDS983028D ;  20) ZALE PUMP CDS , Pack Number CDS983187F ;  21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ;  22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ;  23) ROBOTIC CDS-LF, Pack Number CDS983258O ;  24) ROBOTIC CDS-LF, Pack Number CDS983258Q ;  25) VAGINAL MINOR , Pack Number CDS983268K ;  26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ;  27) ROBOTIC CDS , Pack Number CDS983399D ;  28) GYN VAGINAL CDS , Pack Number CDS983528L ;  29) GYN VAGINAL CDS , Pack Number CDS983528M ;  30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ;  31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ;  32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ;  33) OB CDS, Pack Number CDS983854B ;  34) OB/GYN CDS, Pack Number CDS984173F ;  35) GROTH VAGINAL , Pack Number CDS984201V ;  36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ;  37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ;  38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ;  39) GYN CDS , Pack Number CDS984860G ;  40) OB DELIVERY CDS , Pack Number CDS985027I ;  41) OB/GYN CDS RICE , Pack Number CDS985256C ;  42) OB/GYN CDS RICE , Pack Number CDS985256D ;  43) OB/GYN CDS RICE , Pack Number CDS985256F ;  44) OB CDS-LF , Pack Number CDS985320C ;  45) OB, Pack Number CDS985506D ;  46) OB, Pack Number CDS985506F ;  47) OB, Pack Number CDS985506G ;  48) OB, Pack Number CDS985506I ;  49) GYN LAPAROSCOPY , Pack Number CDS985519L ;  50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ;  51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ;  52) PERI-GYN PACK-LF, Pack Number DYNJ0038057;  53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ;  54) DAVINCI PACK-LF , Pack Number DYNJ0042750;  55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ;  56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ;  57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ;  58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ;  59) D AND C PACK-LF , Pack Number DYNJ0161028C ;  60) D AND C PACK-LF , Pack Number DYNJ0161028F ;  61) D AND C PACK-LF , Pack Number DYNJ0161028G ;  62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ;  63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ;  64) ROBOT PACK, Pack Number DYNJ01823F ;  65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ;  66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ;  67) OB PACK , Pack Number DYNJ03387A ;  68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ;  69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ;  70) OB PACK-LF, Pack Number DYNJ0367126L ;  71) OB PACK-LF, Pack Number DYNJ0367126M ;  72) OB PACK-LF, Pack Number DYNJ0367126N ;  73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ;  74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ;  75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ;  76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ;  77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ;  78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ;  79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ;  80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ;  81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ",
  "description": "FDA recall Z-3050-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;  2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;  3) OB PROCEDURE-LF , Pack Number CDS981335C ;  4) ROBOTIC PACK-LF , Pack Number CDS981757P ;  5) GYN ROBOTIC , Pack Number CDS981826J ;  6) ROBOTIC CDS , Pack Number CDS981882Q ;  7) ROBOTIC CDS , Pack Number CDS981882R ;  8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ;  9) D&C CDS-WRMC, Pack Number CDS982331N ;  10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ;  11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ;  12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ;  13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ;  14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ;  15) GYN/ABDOMINAL , Pack Number CDS982725M ;  16) ROBOTIC CDS , Pack Number CDS982888D ;  17) ROBOTIC CDS , Pack Number CDS982888F ;  18) ROBOTIC CDS , Pack Number CDS982888G ;  19) ROBOTIC CDS , Pack Number CDS983028D ;  20) ZALE PUMP CDS , Pack Number CDS983187F ;  21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ;  22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ;  23) ROBOTIC CDS-LF, Pack Number CDS983258O ;  24) ROBOTIC CDS-LF, Pack Number CDS983258Q ;  25) VAGINAL MINOR , Pack Number CDS983268K ;  26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ;  27) ROBOTIC CDS , Pack Number CDS983399D ;  28) GYN VAGINAL CDS , Pack Number CDS983528L ;  29) GYN VAGINAL CDS , Pack Number CDS983528M ;  30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ;  31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ;  32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ;  33) OB CDS, Pack Number CDS983854B ;  34) OB/GYN CDS, Pack Number CDS984173F ;  35) GROTH VAGINAL , Pack Number CDS984201V ;  36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ;  37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ;  38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ;  39) GYN CDS , Pack Number CDS984860G ;  40) OB DELIVERY CDS , Pack Number CDS985027I ;  41) OB/GYN CDS RICE , Pack Number CDS985256C ;  42) OB/GYN CDS RICE , Pack Number CDS985256D ;  43) OB/GYN CDS RICE , Pack Number CDS985256F ;  44) OB CDS-LF , Pack Number CDS985320C ;  45) OB, Pack Number CDS985506D ;  46) OB, Pack Number CDS985506F ;  47) OB, Pack Number CDS985506G ;  48) OB, Pack Number CDS985506I ;  49) GYN LAPAROSCOPY , Pack Number CDS985519L ;  50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ;  51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ;  52) PERI-GYN PACK-LF, Pack Number DYNJ0038057;  53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ;  54) DAVINCI PACK-LF , Pack Number DYNJ0042750;  55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ;  56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ;  57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ;  58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ;  59) D AND C PACK-LF , Pack Number DYNJ0161028C ;  60) D AND C PACK-LF , Pack Number DYNJ0161028F ;  61) D AND C PACK-LF , Pack Number DYNJ0161028G ;  62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ;  63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ;  64) ROBOT PACK, Pack Number DYNJ01823F ;  65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ;  66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ;  67) OB PACK , Pack Number DYNJ03387A ;  68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ;  69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ;  70) OB PACK-LF, Pack Number DYNJ0367126L ;  71) OB PACK-LF, Pack Number DYNJ0367126M ;  72) OB PACK-LF, Pack Number DYNJ0367126N ;  73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ;  74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ;  75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ;  76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ;  77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ;  78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ;  79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ;  80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ;  81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3050-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;  2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;  3) OB PROCEDURE-LF , Pack Number CDS981335C ;  4) ROBOTIC PACK-LF , Pack Number CDS981757P ;  5) GYN ROBOTIC , Pack Number CDS981826J ;  6) ROBOTIC CDS , Pack Number CDS981882Q ;  7) ROBOTIC CDS , Pack Number CDS981882R ;  8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ;  9) D&C CDS-WRMC, Pack Number CDS982331N ;  10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ;  11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ;  12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ;  13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ;  14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ;  15) GYN/ABDOMINAL , Pack Number CDS982725M ;  16) ROBOTIC CDS , Pack Number CDS982888D ;  17) ROBOTIC CDS , Pack Number CDS982888F ;  18) ROBOTIC CDS , Pack Number CDS982888G ;  19) ROBOTIC CDS , Pack Number CDS983028D ;  20) ZALE PUMP CDS , Pack Number CDS983187F ;  21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ;  22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ;  23) ROBOTIC CDS-LF, Pack Number CDS983258O ;  24) ROBOTIC CDS-LF, Pack Number CDS983258Q ;  25) VAGINAL MINOR , Pack Number CDS983268K ;  26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ;  27) ROBOTIC CDS , Pack Number CDS983399D ;  28) GYN VAGINAL CDS , Pack Number CDS983528L ;  29) GYN VAGINAL CDS , Pack Number CDS983528M ;  30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ;  31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ;  32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ;  33) OB CDS, Pack Number CDS983854B ;  34) OB/GYN CDS, Pack Number CDS984173F ;  35) GROTH VAGINAL , Pack Number CDS984201V ;  36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ;  37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ;  38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ;  39) GYN CDS , Pack Number CDS984860G ;  40) OB DELIVERY CDS , Pack Number CDS985027I ;  41) OB/GYN CDS RICE , Pack Number CDS985256C ;  42) OB/GYN CDS RICE , Pack Number CDS985256D ;  43) OB/GYN CDS RICE , Pack Number CDS985256F ;  44) OB CDS-LF , Pack Number CDS985320C ;  45) OB, Pack Number CDS985506D ;  46) OB, Pack Number CDS985506F ;  47) OB, Pack Number CDS985506G ;  48) OB, Pack Number CDS985506I ;  49) GYN LAPAROSCOPY , Pack Number CDS985519L ;  50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ;  51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ;  52) PERI-GYN PACK-LF, Pack Number DYNJ0038057;  53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ;  54) DAVINCI PACK-LF , Pack Number DYNJ0042750;  55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ;  56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ;  57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ;  58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ;  59) D AND C PACK-LF , Pack Number DYNJ0161028C ;  60) D AND C PACK-LF , Pack Number DYNJ0161028F ;  61) D AND C PACK-LF , Pack Number DYNJ0161028G ;  62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ;  63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ;  64) ROBOT PACK, Pack Number DYNJ01823F ;  65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ;  66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ;  67) OB PACK , Pack Number DYNJ03387A ;  68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ;  69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ;  70) OB PACK-LF, Pack Number DYNJ0367126L ;  71) OB PACK-LF, Pack Number DYNJ0367126M ;  72) OB PACK-LF, Pack Number DYNJ0367126N ;  73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ;  74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ;  75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ;  76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ;  77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ;  78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ;  79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ;  80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ;  81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3050-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3050-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;  2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;  3) OB PROCEDURE-LF , Pack Number CDS981335C ;  4) ROBOTIC PACK-LF , Pack Number CDS981757P ;  5) GYN ROBOTIC , Pack Number CDS981826J ;  6) ROBOTIC CDS , Pack Number CDS981882Q ;  7) ROBOTIC CDS , Pack Number CDS981882R ;  8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ;  9) D&C CDS-WRMC, Pack Number CDS982331N ;  10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ;  11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ;  12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ;  13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ;  14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ;  15) GYN/ABDOMINAL , Pack Number CDS982725M ;  16) ROBOTIC CDS , Pack Number CDS982888D ;  17) ROBOTIC CDS , Pack Number CDS982888F ;  18) ROBOTIC CDS , Pack Number CDS982888G ;  19) ROBOTIC CDS , Pack Number CDS983028D ;  20) ZALE PUMP CDS , Pack Number CDS983187F ;  21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ;  22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ;  23) ROBOTIC CDS-LF, Pack Number CDS983258O ;  24) ROBOTIC CDS-LF, Pack Number CDS983258Q ;  25) VAGINAL MINOR , Pack Number CDS983268K ;  26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ;  27) ROBOTIC CDS , Pack Number CDS983399D ;  28) GYN VAGINAL CDS , Pack Number CDS983528L ;  29) GYN VAGINAL CDS , Pack Number CDS983528M ;  30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ;  31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ;  32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ;  33) OB CDS, Pack Number CDS983854B ;  34) OB/GYN CDS, Pack Number CDS984173F ;  35) GROTH VAGINAL , Pack Number CDS984201V ;  36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ;  37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ;  38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ;  39) GYN CDS , Pack Number CDS984860G ;  40) OB DELIVERY CDS , Pack Number CDS985027I ;  41) OB/GYN CDS RICE , Pack Number CDS985256C ;  42) OB/GYN CDS RICE , Pack Number CDS985256D ;  43) OB/GYN CDS RICE , Pack Number CDS985256F ;  44) OB CDS-LF , Pack Number CDS985320C ;  45) OB, Pack Number CDS985506D ;  46) OB, Pack Number CDS985506F ;  47) OB, Pack Number CDS985506G ;  48) OB, Pack Number CDS985506I ;  49) GYN LAPAROSCOPY , Pack Number CDS985519L ;  50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ;  51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ;  52) PERI-GYN PACK-LF, Pack Number DYNJ0038057;  53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ;  54) DAVINCI PACK-LF , Pack Number DYNJ0042750;  55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ;  56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ;  57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ;  58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ;  59) D AND C PACK-LF , Pack Number DYNJ0161028C ;  60) D AND C PACK-LF , Pack Number DYNJ0161028F ;  61) D AND C PACK-LF , Pack Number DYNJ0161028G ;  62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ;  63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ;  64) ROBOT PACK, Pack Number DYNJ01823F ;  65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ;  66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ;  67) OB PACK , Pack Number DYNJ03387A ;  68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ;  69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ;  70) OB PACK-LF, Pack Number DYNJ0367126L ;  71) OB PACK-LF, Pack Number DYNJ0367126M ;  72) OB PACK-LF, Pack Number DYNJ0367126N ;  73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ;  74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ;  75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ;  76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ;  77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ;  78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ;  79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ;  80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ;  81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ",
      "text": "The FDA logged enforcement record Z-3050-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;  2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;  3) OB PROCEDURE-LF , Pack Number CDS981335C ;  4) ROBOTIC PACK-LF , Pack Number CDS981757P ;  5) GYN ROBOTIC , Pack Number CDS981826J ;  6) ROBOTIC CDS , Pack Number CDS981882Q ;  7) ROBOTIC CDS , Pack Number CDS981882R ;  8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ;  9) D&C CDS-WRMC, Pack Number CDS982331N ;  10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ;  11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ;  12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ;  13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ;  14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ;  15) GYN/ABDOMINAL , Pack Number CDS982725M ;  16) ROBOTIC CDS , Pack Number CDS982888D ;  17) ROBOTIC CDS , Pack Number CDS982888F ;  18) ROBOTIC CDS , Pack Number CDS982888G ;  19) ROBOTIC CDS , Pack Number CDS983028D ;  20) ZALE PUMP CDS , Pack Number CDS983187F ;  21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ;  22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ;  23) ROBOTIC CDS-LF, Pack Number CDS983258O ;  24) ROBOTIC CDS-LF, Pack Number CDS983258Q ;  25) VAGINAL MINOR , Pack Number CDS983268K ;  26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ;  27) ROBOTIC CDS , Pack Number CDS983399D ;  28) GYN VAGINAL CDS , Pack Number CDS983528L ;  29) GYN VAGINAL CDS , Pack Number CDS983528M ;  30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ;  31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ;  32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ;  33) OB CDS, Pack Number CDS983854B ;  34) OB/GYN CDS, Pack Number CDS984173F ;  35) GROTH VAGINAL , Pack Number CDS984201V ;  36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ;  37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ;  38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ;  39) GYN CDS , Pack Number CDS984860G ;  40) OB DELIVERY CDS , Pack Number CDS985027I ;  41) OB/GYN CDS RICE , Pack Number CDS985256C ;  42) OB/GYN CDS RICE , Pack Number CDS985256D ;  43) OB/GYN CDS RICE , Pack Number CDS985256F ;  44) OB CDS-LF , Pack Number CDS985320C ;  45) OB, Pack Number CDS985506D ;  46) OB, Pack Number CDS985506F ;  47) OB, Pack Number CDS985506G ;  48) OB, Pack Number CDS985506I ;  49) GYN LAPAROSCOPY , Pack Number CDS985519L ;  50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ;  51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ;  52) PERI-GYN PACK-LF, Pack Number DYNJ0038057;  53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ;  54) DAVINCI PACK-LF , Pack Number DYNJ0042750;  55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ;  56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ;  57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ;  58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ;  59) D AND C PACK-LF , Pack Number DYNJ0161028C ;  60) D AND C PACK-LF , Pack Number DYNJ0161028F ;  61) D AND C PACK-LF , Pack Number DYNJ0161028G ;  62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ;  63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ;  64) ROBOT PACK, Pack Number DYNJ01823F ;  65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ;  66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ;  67) OB PACK , Pack Number DYNJ03387A ;  68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ;  69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ;  70) OB PACK-LF, Pack Number DYNJ0367126L ;  71) OB PACK-LF, Pack Number DYNJ0367126M ;  72) OB PACK-LF, Pack Number DYNJ0367126N ;  73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ;  74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ;  75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ;  76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ;  77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ;  78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ;  79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ;  80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ;  81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: CDS830039AD, Lot Number 19CBH292 ;  CDS830039AD, Lot Number 19PBC608 ;  CDS840214P , Lot Number 21FBN852 ;  CDS840214P , Lot Number 21HBB376 ;  CDS840214P , Lot Number 21HBF491 ;  CDS840214P , Lot Number 21IBO111 ;  CDS840214P , Lot Number 22ABD314 ;  CDS840214P , Lot Number 22BBI956 ;  CDS840214P , Lot Number 22HBP289 ;  CDS840214P , Lot Number 22IBO308 ;  CDS840214P , Lot Number 22IBR971 ;  CDS840214P , Lot Number 22KBN497 ;  CDS840214P , Lot Number 20JBQ048 ;  CDS840214P , Lot Number 20KBG189 ;  CDS840214P , Lot Number 20KBY177 ;  CDS840214P , Lot Number 21BBC946 ;  CDS981335C , Lot Number 21GBL170 ;  CDS981335C , Lot Number 21HBB530 ;  CDS981335C , Lot Number 21WBA896 ;  CDS981335C , Lot Number 22NBC853 ;  CDS981335C , Lot Number 22OBB104 ;  CDS981335C , Lot Number 22IBP869 ;  CDS981335C , Lot Number 20GBI170 ;  CDS981335C , Lot Number 20KBR144 ;  CDS981335C , Lot Number 21BBE035 ;  CDS981335C , Lot Number 21BBL646 ;  CDS981335C , Lot Number 21EBH220 ;  CDS981757P , Lot Number 21FMB526 ;  CDS981757P , Lot Number 21FMD778 ;  CDS981757P , Lot Number 21GMB729 ;  CDS981757P , Lot Number 21HMF534 ;  CDS981757P , Lot Number 21KMD539 ;  CDS981757P , Lot Number 21LMC014 ;  CDS981757P , Lot Number 22AMF312 ;  CDS981757P , Lot Number 20HKC001 ;  CDS981757P , Lot Number 20LKA498 ;  CDS981757P , Lot Number 21DKA317 ;  CDS981757P , Lot Number 21EKA037 ;  CDS981826J , Lot Number 21FBR364 ;  CDS981826J , Lot Number 21IBE988 ;  CDS981826J , Lot Number 21VBB532 ;  CDS981826J , Lot Number 21LBO570 ;  CDS981826J , Lot Number 21LBO574 ;  CDS981826J , Lot Number 22CBA147 ;  CDS981826J , Lot Number 19ABX512 ;  CDS981826J , Lot Number 19CBO432 ;  CDS981826J , Lot Number 22DBM116 ;  CDS981826J , Lot Number 22EBB425 ;  CDS981826J , Lot Number 19EBK468 ;  CDS981826J , Lot Number 22GBU016 ;  CDS981826J , Lot Number 19FBW726 ;  CDS981826J , Lot Number 22HBN374 ;  CDS981826J , Lot Number 22IBA569 ;  CDS981826J , Lot Number 19HBD972 ;  CDS981826J , Lot Number 22JBI776 ;  CDS981826J , Lot Number 19IBD508 ;  CDS981826J , Lot Number 22KBD576 ;  CDS981826J , Lot Number 19IBP473 ;  CDS981826J , Lot Number 22LBM177 ;  CDS981826J , Lot Number 23ABL468 ;  CDS981826J , Lot Number 19KBT872 ;  CDS981826J , Lot Number 19LBY107 ;  CDS981826J , Lot Number 23DBT137 ;  CDS981826J , Lot Number 23EBK904 ;  CDS981826J , Lot Number 23EBW563 ;  CDS981826J , Lot Number 20BBQ533 ;  CDS981826J , Lot Number 23FBL903 ;  CDS981826J , Lot Number 20CBC257 ;  CDS981826J , Lot Number 23GBP568 ;  CDS981826J , Lot Number 20FBA574 ;  CDS981826J , Lot Number 23IBU308 ;  CDS981826J , Lot Number 23IBW118 ;  CDS981826J , Lot Number 23KBL301 ;  CDS981826J , Lot Number 20HBU183 ;  CDS981826J , Lot Number 24CBA387 ;  CDS981826J , Lot Number 24CBG312 ;  CDS981826J , Lot Number 20KBT694 ;  CDS981826J , Lot Number 20LBR755 ;  CDS981826J , Lot Number 20LBU444 ;  CDS981826J , Lot Number 21BBD223 ;  CDS981826J , Lot Number 21BBR536 ;  CDS981826J , Lot Number 21CBO855 ;  CDS981826J , Lot Number 21CBR551 ;  CDS981882Q , Lot Number 19PBB582 ;  CDS981882Q , Lot Number 19GBP429 ;  CDS981882Q , Lot Number 19HBR905 ;  CDS981882Q , Lot Number 19JBQ808 ;  CDS981882R , Lot Number 19JBS122 ;  CDS981882R , Lot Number 19LBF118 ;  CDS981984I , Lot Number 21IBP860 ;  CDS981984I , Lot Number 21KBD858 ;  CDS981984I , Lot Number 19BBK784 ;  CDS981984I , Lot Number 19BBR887 ;  CDS981984I , Lot Number 19CBI615 ;  CDS981984I , Lot Number 22OBI060 ;  CDS981984I , Lot Number 19EBQ351 ;  CDS981984I , Lot Number 22HBF738 ;  CDS981984I , Lot Number 22IBN140 ;  CDS981984I , Lot Number 19HBK974 ;  CDS981984I , Lot Number 22JBP284 ;  CDS981984I , Lot Number 22KBF154 ;  CDS981984I , Lot Number 23ABH884 ;  CDS981984I , Lot Number 23ABT088 ;  CDS981984I , Lot Number 23BBU118 ;  CDS981984I , Lot Number 23BBU913 ;  CDS981984I , Lot Number 23CBM167 ;  CDS981984I , Lot Number 20ABG963 ;  CDS981984I , Lot Number 23EBN576 ;  CDS981984I , Lot Number 20BBI298 ;  CDS981984I , Lot Number 23GBW025 ;  CDS981984I , Lot Number 20DBG987 ;  CDS981984I , Lot Number 20EBO956 ;  CDS981984I , Lot Number 23KBK041 ;  CDS981984I , Lot Number 23LBD384 ;  CDS981984I , Lot Number 20JBR239 ;  CDS981984I , Lot Number 20KBU642 ;  CDS981984I , Lot Number 20LBP817 ;  CDS981984I , Lot Number 21BBB755 ;  CDS981984I , Lot Number 21CBE512 ;  CDS981984I , Lot Number 21DBI758 ;  CDS981984I , Lot Number 21DBY148 ;  CDS981984I , Lot Number 22CLA775 ;  CDS982331N , Lot Number 23FBO186 ;  CDS982331N , Lot Number 23IBT119 ;  CDS982331N , Lot Number 23JBW645 ;  CDS982331N , Lot Number 23KBP687 ;  CDS982331N , Lot Number 24ABM130 ;  CDS982333O , Lot Number 23GBT894 ;  CDS982333O , Lot Number 23IBQ626 ;  CDS982333O , Lot Number 23JBF455 ;  CDS982333P , Lot Number 23KBP662 ;  CDS982333P , Lot Number 23LBS967 ;  CDS982377G , Lot Number 19ABR698 ;  CDS982377G , Lot Number 19BBS890 ;  CDS982397B , Lot Number 21GBC711 ;  CDS982397B , Lot Number 21HBE154 ;  CDS982397B , Lot Number 21JBI916 ;  CDS982397B , Lot Number 19BBM033 ;  CDS982397B , Lot Number 19CBH369 ;  CDS982397B , Lot Number 19DBL294 ;  CDS982397B , Lot Number 19DBV544 ;  CDS982397B , Lot Number 19EBR006 ;  CDS982397B , Lot Number 19FBZ758 ;  CDS982397B , Lot Number 19SBG230 ;  CDS982397B , Lot Number 19HBN857 ;  CDS982397B , Lot Number 19JBT821 ;  CDS982397B , Lot Number 19LBO309 ;  CDS982397B , Lot Number 20ABN427 ;  CDS982397B , Lot Number 20BBE609 ;  CDS982397B , Lot Number 20EBV316 ;  CDS982397B , Lot Number 20GBU953 ;  CDS982397B , Lot Number 20KBQ006 ;  CDS982397B , Lot Number 21ABS087 ;  CDS982397B , Lot Number 21CBY314 ;  CDS982397B , Lot Number 21EBA181 ;  CDS982407N , Lot Number 21HBR933 ;  CDS982407N , Lot Number 21IBA124 ;  CDS982407N , Lot Number 19FBE601 ;  CDS982407N , Lot Number 19GBR812 ;  CDS982407N , Lot Number 19HBY614 ;  CDS982407N , Lot Number 19IBP675 ;  CDS982407N , Lot Number 19JBR316 ;  CDS982407N , Lot Number 19VBA672 ;  CDS982407N , Lot Number 20CBX761 ;  CDS982407N , Lot Number 20DBV869 ;  CDS982407N , Lot Number 20FBB987 ;  CDS982407N , Lot Number 20GBD747 ;  CDS982407N , Lot Number 20GBQ181 ;  CDS982407N , Lot Number 20HBG094 ;  CDS982407N , Lot Number 20IBO544 ;  CDS982407N , Lot Number 20IBO700 ;  CDS982407N , Lot Number 20KBH410 ;  CDS982407N , Lot Number 20KBJ015 ;  CDS982407N , Lot Number 21CBD150 ;  CDS982407N , Lot Number 21DBO201 ;  CDS982407N , Lot Number 21FBH136 ;  CDS982725M , Lot Number 21FBI678 ;  CDS982725M , Lot Number 21HBA025 ;  CDS982725M , Lot Number 21HBT649 ;  CDS982725M , Lot Number 21JBX792 ;  CDS982725M , Lot Number 22BBL928 ;  CDS982725M , Lot Number 22FBB426 ;  CDS982725M , Lot Number 22HBF739 ;  CDS982888D , Lot Number 19ABH707 ;  CDS982888F , Lot Number 19BBC785 ;  CDS982888F , Lot Number 19BBR212 ;  CDS982888F , Lot Number 19PBB698 ;  CDS982888F , Lot Number 19PBC886 ;  CDS982888F , Lot Number 19QBB894 ;  CDS982888G , Lot Number 19HBP405 ;  CDS982888G , Lot Number 19HBT021 ;  CDS982888G , Lot Number 19TBB421 ;  CDS982888G , Lot Number 19IBV342 ;  CDS982888G , Lot Number 19KBA176 ;  CDS982888G , Lot Number 19KBZ824 ;  CDS983028D , Lot Number 19ABH844 ;  CDS983028D , Lot Number 19BBO280 ;  CDS983028D , Lot Number 19CBN005 ;  CDS983028D , Lot Number 19PBB799 ;  CDS983028D , Lot Number 19FBT105 ;  CDS983028D , Lot Number 19IBA387 ;  CDS983187F , Lot Number 21IBJ817 ;  CDS983187F , Lot Number 21IBP797 ;  CDS983187F , Lot Number 21IBP798 ;  CDS983187F , Lot Number 21KBA432 ;  CDS983187F , Lot Number 21LBV084 ;  CDS983187F , Lot Number 22BBA316 ;  CDS983187F , Lot Number 19CBF206 ;  CDS983187F , Lot Number 19DBJ632 ;  CDS983187F , Lot Number 22EBM612 ;  CDS983187F , Lot Number 22EBQ486 ;  CDS983187F , Lot Number 19EBM749 ;  CDS983187F , Lot Number 19FBO257 ;  CDS983187F , Lot Number 22HBS845 ;  CDS983187F , Lot Number 22IBD862 ;  CDS983187F , Lot Number 22JBA824 ;  CDS983187F , Lot Number 19HBZ088 ;  CDS983187F , Lot Number 19IBD306 ;  CDS983187F , Lot Number 19JBT686 ;  CDS983187F , Lot Number 20ABL838 ;  CDS983187F , Lot Number 20CBB783 ;  CDS983187F , Lot Number 20CBF497 ;  CDS983187F , Lot Number 20CBW531 ;  CDS983187F , Lot Number 20EBI798 ;  CDS983187F , Lot Number 20FBI369 ;  CDS983187F , Lot Number 20HBC286 ;  CDS983187F , Lot Number 20JBO733 ;  CDS983187F , Lot Number 20LBO434 ;  CDS983187F , Lot Number 20XBI626 ;  CDS983187F , Lot Number 21CBV530 ;  CDS983187F , Lot Number 21FBD645 ;  CDS983187F , Lot Number 21FBE341 ;  CDS983190L , Lot Number 21HBG895 ;  CDS983190L , Lot Number 21IBL907 ;  CDS983190L , Lot Number 21JBP547 ;  CDS983190L , Lot Number 22ABF852 ;  CDS983190L , Lot Number 22ABI219 ;  CDS983190L , Lot Number 22ABZ198 ;  CDS983190L , Lot Number 22OBM702 ;  CDS983190L , Lot Number 22EBE865 ;  CDS983190L , Lot Number 22EBO246 ;  CDS983190L , Lot Number 20CBY260 ;  CDS983190L , Lot Number 20GBG574 ;  CDS983190L , Lot Number 20IBD185 ;  CDS983190L , Lot Number 20JBF190 ;  CDS983190L , Lot Number 20JBK089 ;  CDS983190L , Lot Number 20KBH298 ;  CDS983190L , Lot Number 21BBM487 ;  CDS983190L , Lot Number 21DBA512 ;  CDS983190L , Lot Number 21DBS599 ;  CDS983190L , Lot Number 21FBH234 ;  CDS983216I , Lot Number 21FMC084 ;  CDS983216I , Lot Number 21KME577 ;  CDS983216I , Lot Number 21LMA223 ;  CDS983216I , Lot Number 19DKB865 ;  CDS983216I , Lot Number 19FKB746 ;  CDS983216I , Lot Number 19FKC261 ;  CDS983216I , Lot Number 19GKC764 ;  CDS983216I , Lot Number 19HKC570 ;  CDS983216I , Lot Number 19KKA061 ;  CDS983216I , Lot Number 20CKA293 ;  CDS983216I , Lot Number 20FKB303 ;  CDS983216I , Lot Number 20IKA578 ;  CDS983216I , Lot Number 20JKA229 ;  CDS983216I , Lot Number 20JKB178 ;  CDS983258O , Lot Number 19BKD021 ;  CDS983258O , Lot Number 19CKB235 ;  CDS983258O , Lot Number 19DKA634 ;  CDS983258O , Lot Number 19EKB872 ;  CDS983258Q , Lot Number 19LKA040 ;  CDS983258Q , Lot Number 20AKC225 ;  CDS983258Q , Lot Number 20EKA166 ;  CDS983258Q , Lot Number 20HKB828 ;  CDS983258Q , Lot Number 20LKB145 ;  CDS983268K , Lot Number 22EBU315 ;  CDS983268K , Lot Number 22FBA922 ;  CDS983268K , Lot Number 22HBT919 ;  CDS983268K , Lot Number 22JBR892 ;  CDS983375K , Lot Number 21FBT747 ;  CDS983375K , Lot Number 21HBO571 ;  CDS983375K , Lot Number 21KBB372 ;  CDS983375K , Lot Number 21LBT967 ;  CDS983375K , Lot Number 22ABH931 ;  CDS983375K , Lot Number 22BBE846 ;  CDS983375K , Lot Number 22OBL286 ;  CDS983375K , Lot Number 22EBQ746 ;  CDS983375K , Lot Number 21DBC044 ;  CDS983375K , Lot Number 21DBD644 ;  CDS983375K , Lot Number 21EBO479 ;  CDS983399D , Lot Number 19BDA410 ;  CDS983399D , Lot Number 19DDA367 ;  CDS983399D , Lot Number 19DDD080 ;  CDS983399D , Lot Number 19EDB946 ;  CDS983399D , Lot Number 19FDA746 ;  CDS983399D , Lot Number 19GDB539 ;  CDS983399D , Lot Number 19IDB070 ;  CDS983399D , Lot Number 19JDB137 ;  CDS983399D , Lot Number 19KDA249 ;  CDS983399D , Lot Number 19LDB389 ;  CDS983399D , Lot Number 20ADC092 ;  CDS983399D , Lot Number 20BDB503 ;  CDS983399D , Lot Number 20CDA897 ;  CDS983399D , Lot Number 20DDB453 ;  CDS983399D , Lot Number 20EDA505 ;  CDS983399D , Lot Number 20FDC137 ;  CDS983399D , Lot Number 20GDA649 ;  CDS983399D , Lot Number 20HDB922 ;  CDS983528L , Lot Number 22LBF933 ; 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A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3050-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3050-2024&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3050-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3050-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
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        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3050-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3050-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3050-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
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 DYNJ0042750, Lot Number 18LBN324 ;  DYNJ0042750, Lot Number 19ABZ498 ;  DYNJ0042750, Lot Number 19FBE166 ;  DYNJ0042750, Lot Number 19GBC843 ;  DYNJ0042750, Lot Number 19GBI214 ;  DYNJ0042750, Lot Number 19TBB142 ;  DYNJ0042750, Lot Number 19IBO724 ;  DYNJ0042750, Lot Number 19JBA989 ;  DYNJ0042750, Lot Number 19LBA797 ;  DYNJ0046667A , Lot Number 20KMD297 ;  DYNJ0046667A , Lot Number 21AMA700 ;  DYNJ0046667A , Lot Number 21AMB340 ;  DYNJ0046667A , Lot Number 21CMA516 ;  DYNJ0046667A , Lot Number 21CME251 ;  DYNJ0046667A , Lot Number 21EMB406 ;  DYNJ0046667A , Lot Number 21FMC522 ;  DYNJ0046667A , Lot Number 21GMC932 ;  DYNJ0046667A , Lot Number 21HME119 ;  DYNJ0046667A , Lot Number 21KMF215 ;  DYNJ0046667A , Lot Number 21LMB634 ;  DYNJ0046667A , Lot Number 22AMB834 ;  DYNJ0046667A , Lot Number 22BMF198 ;  DYNJ0046667A , Lot Number 22CMD979 ;  DYNJ0046667A , Lot Number 22EMB660 ;  DYNJ0046667A , Lot Number 22EMB661 ;  DYNJ0046667A , Lot Number 22EMB662 ;  DYNJ0046667A , Lot Number 22IMC899 ; 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 DYNJ0048814I , Lot Number 21HMD222 ;  DYNJ0048814I , Lot Number 21IMF561 ;  DYNJ0048814I , Lot Number 21JMG514 ;  DYNJ0048814I , Lot Number 21KMI266 ;  DYNJ0048814I , Lot Number 22BME009 ;  DYNJ0048814I , Lot Number 22DMD093 ;  DYNJ0048814I , Lot Number 22FMF108 ;  DYNJ0048814I , Lot Number 22FMG432 ;  DYNJ0048814I , Lot Number 22HMD759 ;  DYNJ0048814I , Lot Number 22HMD765 ;  DYNJ0048814I , Lot Number 22KME286 ;  DYNJ0048814I , Lot Number 22LMI976 ;  DYNJ0048814I , Lot Number 23AMJ582 ;  DYNJ0048814I , Lot Number 23DMB073 ;  DYNJ0048814I , Lot Number 23DMB514 ;  DYNJ0048814I , Lot Number 23EMF593 ;  DYNJ0048814I , Lot Number 23FMC869 ;  DYNJ0048814I , Lot Number 23GMC447 ;  DYNJ0048814I , Lot Number 23HMF942 ;  DYNJ0048814I , Lot Number 23IMD431 ;  DYNJ0048814I , Lot Number 23JMF980 ;  DYNJ0048814I , Lot Number 23JMK171 ;  DYNJ0048814I , Lot Number 24AMB862 ;  DYNJ0101440F , Lot Number 19BDC693 ;  DYNJ0101440F , Lot Number 19DDB658 ;  DYNJ0101440F , Lot Number 19EDB188 ;  DYNJ0101440F , Lot Number 19FDC438 ;  DYNJ0101440F , Lot Number 19GDC715 ;  DYNJ0101440F , Lot Number 19IDB767 ;  DYNJ0101440F , Lot Number 19LMB454 ;  DYNJ0101440F , Lot Number 20AMA643 ;  DYNJ0101440F , Lot Number 20BMB949 ;  DYNJ0101440F , Lot Number 20CMB775 ;  DYNJ0101440F , Lot Number 20GMC523 ;  DYNJ0101440F , Lot Number 20IMB735 ;  DYNJ0101440F , Lot Number 20JMA264 ;  DYNJ0101440F , Lot Number 20KMB368 ;  DYNJ0101440F , Lot Number 21BMD687 ;  DYNJ0101440F , Lot Number 21DMC586 ;  DYNJ0101440F , Lot Number 21FMA150 ;  DYNJ0101440F , Lot Number 21GMG063 ;  DYNJ0101440F , Lot Number 21IMA367 ;  DYNJ0101440F , Lot Number 21IMH440 ;  DYNJ0101440F , Lot Number 21KMD025 ;  DYNJ0103039B , Lot Number 19ADA367 ;  DYNJ0103039B , Lot Number 19CDD103 ;  DYNJ0161028C , Lot Number 19ADC011 ;  DYNJ0161028C , Lot Number 19CDA870 ;  DYNJ0161028C , Lot Number 19EDA114 ;  DYNJ0161028C , Lot Number 19FDB524 ;  DYNJ0161028C , Lot Number 19IDA737 ;  DYNJ0161028F , Lot Number 20EDA596 ;  DYNJ0161028F , Lot Number 20JDB324 ;  DYNJ0161028F , Lot Number 20JDC502 ;  DYNJ0161028G , Lot Number 21DDB217 ;  DYNJ0161028G , Lot Number 21GDA335 ;  DYNJ0161028G , Lot Number 21HDC070 ;  DYNJ0161028G , Lot Number 21IDA562 ;  DYNJ0161028G , Lot Number 21KDC462 ;  DYNJ0161028G , Lot Number 22ADB295 ;  DYNJ0161028G , Lot Number 22DDA643 ;  DYNJ0161028G , Lot Number 22DDB627 ;  DYNJ0161028G , Lot Number 22EDB700 ;  DYNJ0161028G , Lot Number 22GDA540 ;  DYNJ0161028G , Lot Number 22HDA931 ;  DYNJ0161028G , Lot Number 22KDB649 ;  DYNJ0161028G , Lot Number 23BDA264 ;  DYNJ0161028G , Lot Number 23DDB356 ;  DYNJ0161028G , Lot Number 23EDA344 ;  DYNJ0161028G , Lot Number 23FDC346 ;  DYNJ0161028G , Lot Number 23IDC048 ;  DYNJ0161028G , Lot Number 23JDB943 ;  DYNJ0161619D , Lot Number 19AKB976 ;  DYNJ0161619D , Lot Number 19BKD074 ;  DYNJ0161619D , Lot Number 19DKB509 ;  DYNJ0161619D , Lot Number 19FKB813 ;  DYNJ0161619D , Lot Number 19HKA978 ;  DYNJ0161619D , Lot Number 19JKA533 ;  DYNJ0161619D , Lot Number 20AKB333 ;  DYNJ0161619D , Lot Number 20CKA394 ;  DYNJ0161811C , Lot Number 19CDC684 ;  DYNJ0161811C , Lot Number 19EDA550 ;  DYNJ0161811C , Lot Number 19EDC488 ;  DYNJ0161811C , Lot Number 19FDB927 ;  DYNJ0161811C , Lot Number 19HDD314 ;  DYNJ0161811C , Lot Number 19JDC797 ;  DYNJ01823F , Lot Number 20LMC392 ;  DYNJ01823F , Lot Number 21DMB766 ;  DYNJ01823F , Lot Number 21DME688 ;  DYNJ01823F , Lot Number 21FME184 ;  DYNJ01823F , Lot Number 19AKD454 ;  DYNJ01823F , Lot Number 19EKA563 ;  DYNJ01823F , Lot Number 19FKA054 ;  DYNJ01823F , Lot Number 19GKA379 ;  DYNJ01823F , Lot Number 19HKC508 ;  DYNJ01823F , Lot Number 19JKB294 ;  DYNJ01823F , Lot Number 19KKB652 ;  DYNJ01823F , Lot Number 20AKB524 ;  DYNJ01823F , Lot Number 20CKB333 ;  DYNJ0193529A , Lot Number 19CKA325 ;  DYNJ0193529A , Lot Number 19DKC680 ;  DYNJ0193529A , Lot Number 19HKB577 ;  DYNJ0193529A , Lot Number 19JKA066 ;  DYNJ0193529A , Lot Number 19KKA094 ;  DYNJ0193529A , Lot Number 19KKA289 ;  DYNJ0193529A , Lot Number 19LKA299 ;  DYNJ0193529A , Lot Number 19LKB456 ;  DYNJ0193529A , Lot Number 20AKB916 ;  DYNJ0193529A , Lot Number 20CKA033 ;  DYNJ0193529A , Lot Number 20CKA077 ;  DYNJ0287784R , Lot Number 20IMD811 ;  DYNJ0287784R , Lot Number 20JME846 ;  DYNJ0287784R , Lot Number 20KMC334 ;  DYNJ0287784R , Lot Number 20KMF037 ;  DYNJ0287784R , Lot Number 21CMA547 ;  DYNJ0287784R , Lot Number 21CMA849 ;  DYNJ0287784R , Lot Number 21DMA937 ;  DYNJ0287784R , Lot Number 21EMD164 ;  DYNJ0287784R , Lot Number 21FMF514 ;  DYNJ0287784R , Lot Number 21GME374 ;  DYNJ0287784R , Lot Number 21HMC513 ;  DYNJ0287784R , Lot Number 21IME464 ;  DYNJ0287784R , Lot Number 21LMG087 ;  DYNJ0287784R , Lot Number 22AMA891 ;  DYNJ0287784R , Lot Number 22AMD731 ;  DYNJ0287784R , Lot Number 22EME354 ;  DYNJ0287784R , Lot Number 22GMF493 ;  DYNJ0287784R , Lot Number 22HMD708 ;  DYNJ0287784R , Lot Number 22HMD709 ;  DYNJ0287784R , Lot Number 22IMC118 ;  DYNJ0287784R , Lot Number 23EMB596 ;  DYNJ0287784R , Lot Number 23FMF477 ;  DYNJ0287784R , Lot Number 23GMB518 ;  DYNJ0287784R , Lot Number 23HMC923 ;  DYNJ0287784R , Lot Number 23HMI493 ;  DYNJ0287784R , Lot Number 23JMA809 ;  DYNJ0287784R , Lot Number 23JMG394 ;  DYNJ0287784R , Lot Number 23KMD177 ;  DYNJ0287784R , Lot Number 23LMC232 ;  DYNJ03387A , Lot Number 21GMD526 ;  DYNJ03387A , Lot Number 21IME838 ;  DYNJ03387A , Lot Number 21IMF945 ;  DYNJ03387A , Lot Number 21KMF815 ;  DYNJ03387A , Lot Number 22BME711 ;  DYNJ03387A , Lot Number 22CMG065 ;  DYNJ0362432L , Lot Number 19BBB944 ;  DYNJ0362432L , Lot Number 19CBN902 ;  DYNJ0362432L , Lot Number 19PBA437 ;  DYNJ0362432L , Lot Number 19FBQ059 ;  DYNJ0362432M , Lot Number 19HBE819 ;  DYNJ0362432M , Lot Number 19IBL032 ;  DYNJ0362432M , Lot Number 19KBK654 ;  DYNJ0362432M , Lot Number 19KBX533 ;  DYNJ0362432M , Lot Number 19LBQ355 ;  DYNJ0362432M , Lot Number 20BBV266 ;  DYNJ0362432M , Lot Number 20CBK549 ;  DYNJ0362432M , Lot Number 20CBM858 ;  DYNJ0362432M , Lot Number 20DBQ583 ;  DYNJ0362432M , Lot Number 20EBV340 ;  DYNJ0362432M , Lot Number 20GBI288 ;  DYNJ0367126L , Lot Number 19PBB239 ;  DYNJ0367126L , Lot Number 19EBC471 ;  DYNJ0367126L , Lot Number 19FBS890 ;  DYNJ0367126L , Lot Number 19GBO841 ;  DYNJ0367126L , Lot Number 19HBH497 ;  DYNJ0367126L , Lot Number 19AKC620 ;  DYNJ0367126L , Lot Number 19BKA779 ;  DYNJ0367126L , Lot Number 19DKB494 ;  DYNJ0367126M , Lot Number 19IBQ205 ;  DYNJ0367126M , Lot Number 19VBB532 ;  DYNJ0367126M , Lot Number 19KBI378 ;  DYNJ0367126N , Lot Number 19LBL376 ;  DYNJ0367126N , Lot Number 20BBI172 ;  DYNJ0367126N , Lot Number 20BBR282 ;  DYNJ0367126N , Lot Number 20CBQ313 ;  DYNJ0367126N , Lot Number 20EBE843 ;  DYNJ0367126N , Lot Number 20EBP181 ;  DYNJ0367126N , Lot Number 20IMC139 ;  DYNJ0367126N , Lot Number 20LMC957 ;  DYNJ0367126N , Lot Number 21AMA703 ;  DYNJ0367126N , Lot Number 21BMA176 ;  DYNJ0367126N , Lot Number 21BMD749 ;  DYNJ0367126N , Lot Number 21EMB032 ;  DYNJ0367126N , Lot Number 21FMC390 ;  DYNJ0367126N , Lot Number 21GMF918 ;  DYNJ0367126N , Lot Number 21HME287 ;  DYNJ0367126N , Lot Number 21IMD629 ;  DYNJ0367126N , Lot Number 21KMB761 ;  DYNJ0367126N , Lot Number 22AMA629 ;  DYNJ0367126N , Lot Number 22BMA660 ;  DYNJ0367126N , Lot Number 22CMD023 ;  DYNJ0367126N , Lot Number 22EME554 ;  DYNJ0367126N , Lot Number 22GMG636 ;  DYNJ0367126N , Lot Number 22HMD394 ;  DYNJ0367126N , Lot Number 22IMD2",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}