{ "@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-1117-2024.jsonld", "@type": "schema:Dataset", "name": "Medline Kits, trays, and packs labeled as follows: a)\tCENTRAL LINE TRAY, REF CVI4705; b)\tDAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c)\tDRESSING CHANGE TRAY, REF DYNDC3131A; d)\tDRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e)\tDRSG CHANGE TRAY W/ CHG, REF DT21460B; f)\tDRSG CHANGE TRAY W/ CHG, REF DT21460BH; g)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i)\tPEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j)\tPORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k)\tPORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l)\tPORT ACCESS PACK-LF, REF DYNJ0352159D; m)\tPORT DRESSING CHANGE KIT, REF DT22810; n)\tPORT DRESSING CHANGE TRAY, REF DT20640B; o)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052A; p)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937; t)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v)\tADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w)\tA-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x)\tCENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y)\tCENTRAL LINE DRESSING KIT, REF EBSI1088A; z)\tCENTRAL LINE DRESSING KIT, REF EBSI1088B; aa)\tCENTRAL LINE KIT, REF EBSI1245B; bb)\tCENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc)\tCVC DRESSING CHANGE KIT, REF EBSI1472A; dd)\tCVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee)\tCVL DRESSING CHANGE KIT, REF EBSI1547; ff)\tDIALYSIS CHANGE KIT, REF EBSI1453; gg)\tDIALYSIS KIT, REF EBSI1476; hh)\tDRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii)\tDRESSING CHANGE TRAY, REF EBSI1513; jj)\tEBSI DRESSING CHANGE KIT, REF EBSI1163B; kk)\tERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll)\tERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo)\tLARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp)\tOUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq)\tOUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr)\tPACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss)\tPICC DRESSING CHANGE KIT, REF EBSI1471A; tt)\tPICC DRESSING CHANGE TRAY, REF EBSI1512; uu)\tPICC DRESSING CHANGE TRAY, REF EBSI1546; vv)\tPICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww)\tPICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx)\tPORT ACCESS TRAY, REF DYNDC2703A; yy)\tPORT DRESSING CHANGE KIT, REF EBSI1434A; zz)\tPORT DRESSING CHANGE KIT, REF EBSI1525; aaa)\tPORT DRESSING CHANGE KIT, REF EBSI1525; bbb)\tPORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc)\tSMALL BORE DRESSING CHANGE KIT, REF EBSI1556", "description": "FDA recall Z-1117-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows: a)\tCENTRAL LINE TRAY, REF CVI4705; b)\tDAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c)\tDRESSING CHANGE TRAY, REF DYNDC3131A; d)\tDRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e)\tDRSG CHANGE TRAY W/ CHG, REF DT21460B; f)\tDRSG CHANGE TRAY W/ CHG, REF DT21460BH; g)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i)\tPEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j)\tPORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k)\tPORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l)\tPORT ACCESS PACK-LF, REF DYNJ0352159D; m)\tPORT DRESSING CHANGE KIT, REF DT22810; n)\tPORT DRESSING CHANGE TRAY, REF DT20640B; o)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052A; p)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937; t)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v)\tADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w)\tA-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x)\tCENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y)\tCENTRAL LINE DRESSING KIT, REF EBSI1088A; z)\tCENTRAL LINE DRESSING KIT, REF EBSI1088B; aa)\tCENTRAL LINE KIT, REF EBSI1245B; bb)\tCENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc)\tCVC DRESSING CHANGE KIT, REF EBSI1472A; dd)\tCVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee)\tCVL DRESSING CHANGE KIT, REF EBSI1547; ff)\tDIALYSIS CHANGE KIT, REF EBSI1453; gg)\tDIALYSIS KIT, REF EBSI1476; hh)\tDRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii)\tDRESSING CHANGE TRAY, REF EBSI1513; jj)\tEBSI DRESSING CHANGE KIT, REF EBSI1163B; kk)\tERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll)\tERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo)\tLARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp)\tOUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq)\tOUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr)\tPACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss)\tPICC DRESSING CHANGE KIT, REF EBSI1471A; tt)\tPICC DRESSING CHANGE TRAY, REF EBSI1512; uu)\tPICC DRESSING CHANGE TRAY, REF EBSI1546; vv)\tPICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww)\tPICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx)\tPORT ACCESS TRAY, REF DYNDC2703A; yy)\tPORT DRESSING CHANGE KIT, REF EBSI1434A; zz)\tPORT DRESSING CHANGE KIT, REF EBSI1525; aaa)\tPORT DRESSING CHANGE KIT, REF EBSI1525; bbb)\tPORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc)\tSMALL BORE DRESSING CHANGE KIT, REF EBSI1556 (Devices, Class I). 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-1117-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medline Kits, trays, and packs labeled as follows: a)\tCENTRAL LINE TRAY, REF CVI4705; b)\tDAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c)\tDRESSING CHANGE TRAY, REF DYNDC3131A; d)\tDRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e)\tDRSG CHANGE TRAY W/ CHG, REF DT21460B; f)\tDRSG CHANGE TRAY W/ CHG, REF DT21460BH; g)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i)\tPEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j)\tPORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k)\tPORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l)\tPORT ACCESS PACK-LF, REF DYNJ0352159D; m)\tPORT DRESSING CHANGE KIT, REF DT22810; n)\tPORT DRESSING CHANGE TRAY, REF DT20640B; o)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052A; p)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937; t)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v)\tADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w)\tA-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x)\tCENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y)\tCENTRAL LINE DRESSING KIT, REF EBSI1088A; z)\tCENTRAL LINE DRESSING KIT, REF EBSI1088B; aa)\tCENTRAL LINE KIT, REF EBSI1245B; bb)\tCENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc)\tCVC DRESSING CHANGE KIT, REF EBSI1472A; dd)\tCVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee)\tCVL DRESSING CHANGE KIT, REF EBSI1547; ff)\tDIALYSIS CHANGE KIT, REF EBSI1453; gg)\tDIALYSIS KIT, REF EBSI1476; hh)\tDRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii)\tDRESSING CHANGE TRAY, REF EBSI1513; jj)\tEBSI DRESSING CHANGE KIT, REF EBSI1163B; kk)\tERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll)\tERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo)\tLARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp)\tOUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq)\tOUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr)\tPACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss)\tPICC DRESSING CHANGE KIT, REF EBSI1471A; tt)\tPICC DRESSING CHANGE TRAY, REF EBSI1512; uu)\tPICC DRESSING CHANGE TRAY, REF EBSI1546; vv)\tPICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww)\tPICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx)\tPORT ACCESS TRAY, REF DYNDC2703A; yy)\tPORT DRESSING CHANGE KIT, REF EBSI1434A; zz)\tPORT DRESSING CHANGE KIT, REF EBSI1525; aaa)\tPORT DRESSING CHANGE KIT, REF EBSI1525; bbb)\tPORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc)\tSMALL BORE DRESSING CHANGE KIT, REF EBSI1556", "manufacturer": { "@type": "schema:Organization", "name": "MEDLINE INDUSTRIES, LP - Northfield" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1117-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1117-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows: a)\tCENTRAL LINE TRAY, REF CVI4705; b)\tDAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c)\tDRESSING CHANGE TRAY, REF DYNDC3131A; d)\tDRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e)\tDRSG CHANGE TRAY W/ CHG, REF DT21460B; f)\tDRSG CHANGE TRAY W/ CHG, REF DT21460BH; g)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i)\tPEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j)\tPORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k)\tPORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l)\tPORT ACCESS PACK-LF, REF DYNJ0352159D; m)\tPORT DRESSING CHANGE KIT, REF DT22810; n)\tPORT DRESSING CHANGE TRAY, REF DT20640B; o)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052A; p)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937; t)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v)\tADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w)\tA-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x)\tCENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y)\tCENTRAL LINE DRESSING KIT, REF EBSI1088A; z)\tCENTRAL LINE DRESSING KIT, REF EBSI1088B; aa)\tCENTRAL LINE KIT, REF EBSI1245B; bb)\tCENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc)\tCVC DRESSING CHANGE KIT, REF EBSI1472A; dd)\tCVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee)\tCVL DRESSING CHANGE KIT, REF EBSI1547; ff)\tDIALYSIS CHANGE KIT, REF EBSI1453; gg)\tDIALYSIS KIT, REF EBSI1476; hh)\tDRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii)\tDRESSING CHANGE TRAY, REF EBSI1513; jj)\tEBSI DRESSING CHANGE KIT, REF EBSI1163B; kk)\tERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll)\tERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo)\tLARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp)\tOUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq)\tOUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr)\tPACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss)\tPICC DRESSING CHANGE KIT, REF EBSI1471A; tt)\tPICC DRESSING CHANGE TRAY, REF EBSI1512; uu)\tPICC DRESSING CHANGE TRAY, REF EBSI1546; vv)\tPICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww)\tPICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx)\tPORT ACCESS TRAY, REF DYNDC2703A; yy)\tPORT DRESSING CHANGE KIT, REF EBSI1434A; zz)\tPORT DRESSING CHANGE KIT, REF EBSI1525; aaa)\tPORT DRESSING CHANGE KIT, REF EBSI1525; bbb)\tPORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc)\tSMALL BORE DRESSING CHANGE KIT, REF EBSI1556", "text": "The FDA logged enforcement record Z-1117-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits, trays, and packs labeled as follows: a)\tCENTRAL LINE TRAY, REF CVI4705; b)\tDAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c)\tDRESSING CHANGE TRAY, REF DYNDC3131A; d)\tDRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e)\tDRSG CHANGE TRAY W/ CHG, REF DT21460B; f)\tDRSG CHANGE TRAY W/ CHG, REF DT21460BH; g)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h)\tLVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i)\tPEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j)\tPORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k)\tPORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l)\tPORT ACCESS PACK-LF, REF DYNJ0352159D; m)\tPORT DRESSING CHANGE KIT, REF DT22810; n)\tPORT DRESSING CHANGE TRAY, REF DT20640B; o)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052A; p)\tPORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r)\tPOST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937; t)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u)\tSALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v)\tADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w)\tA-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x)\tCENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y)\tCENTRAL LINE DRESSING KIT, REF EBSI1088A; z)\tCENTRAL LINE DRESSING KIT, REF EBSI1088B; aa)\tCENTRAL LINE KIT, REF EBSI1245B; bb)\tCENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc)\tCVC DRESSING CHANGE KIT, REF EBSI1472A; dd)\tCVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee)\tCVL DRESSING CHANGE KIT, REF EBSI1547; ff)\tDIALYSIS CHANGE KIT, REF EBSI1453; gg)\tDIALYSIS KIT, REF EBSI1476; hh)\tDRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii)\tDRESSING CHANGE TRAY, REF EBSI1513; jj)\tEBSI DRESSING CHANGE KIT, REF EBSI1163B; kk)\tERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll)\tERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn)\tIJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo)\tLARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp)\tOUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq)\tOUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr)\tPACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss)\tPICC DRESSING CHANGE KIT, REF EBSI1471A; tt)\tPICC DRESSING CHANGE TRAY, REF EBSI1512; uu)\tPICC DRESSING CHANGE TRAY, REF EBSI1546; vv)\tPICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww)\tPICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx)\tPORT ACCESS TRAY, REF DYNDC2703A; yy)\tPORT DRESSING CHANGE KIT, REF EBSI1434A; zz)\tPORT DRESSING CHANGE KIT, REF EBSI1525; aaa)\tPORT DRESSING CHANGE KIT, REF EBSI1525; bbb)\tPORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc)\tSMALL BORE DRESSING CHANGE KIT, REF EBSI1556 — reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: a) REF CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508; k) DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704; l) DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774; m) DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823; n) DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214; o) DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145; p) DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145; q) DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; r) DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; s) DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574; t) DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607; u) DYNDA2937AH, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 23EBK506, 23FBF438, 23HBN471, 23IBN607 v) REF DYNDC3161, UDI/DI 20193489111627 (case), 10193489111620 (unit), Lot Numbers: 2022031480, 2022061380, 2022082980; w) REF EBSI1530, UDI/DI 00653160354195 (case), 10653160354192 (unit), Lot Numbers: 2022082280; x) REF EBSI1489, UDI/DI 20193489111238 (case), 10193489111231 (unit), Lot Numbers: 2022011350, 2022022880, 2022082280; y) REF EBSI1088A, UDI/DI 20193489111726 (case), 10193489111729 (unit), Lot Numbers: 2022022180; z) REF EBSI1088B, UDI/DI 00653160352689 (case), 10653160352686 (unit), Lot Numbers: 2022061380, 2022082280; aa) REF EBSI1245B, UDI/DI 20193489110828 (case), 10193489110821 (unit), Lot Numbers: 2022031480, 2022082280; bb) REF DYNDC2925B, UDI/DI 00653160349832 (case), 10653160349839 (unit), Lot Numbers: 2022012450, 2022021050, 2022022180; cc) REF EBSI1472A, UDI/DI 20193489112594 (case), 10193489112597 (unit), Lot Numbers: 2021122950, 2022021480; dd) REF EBSI1110C, UDI/DI 00653160352269 (case), 10653160352266 (unit), Lot Numbers: 2022052380; ee) REF EBSI1547, UDI/DI 00653160352276 (case), 10653160352273 (unit), Lot Numbers: 2022050980; ff) REF EBSI1453, UDI/DI 20193489110194 (case), 10193489110197 (unit), Lot Numbers: 2022022180, 2022032880; gg) REF EBSI1476, UDI/DI 20193489110156 (case), 10193489110159 (unit), Lot Numbers: 2022012480, 2022082280; hh) REF EBSI1413A, UDI/DI 20193489112198 (case), 10193489112191 (unit), Lot Numbers: 2022031480; ii) REF EBSI1513, UDI/DI 20193489112617 (case), 10193489112610 (unit), Lot Numbers: 2021122950, 2022012480; jj) REF EBSI1163B, UDI/DI 20193489112112 (case), 10193489112115 (unit), Lot Numbers: 2022050980, 2022061380; kk) REF EBSI1415A, UDI/DI 20193489112235 (case), 10193489112238 (unit), Lot Numbers: 2022021650; ll) REF EBSI1161A, UDI/DI 20193489111801 (case), 10193489111804 (unit), Lot Numbers: 2022012480, 2022022880, 2022082280; mm) REF EBSI1524, UDI/DI 00653160349238 (case), 10653160349235 (unit), Lot Numbers: 2021122950, 2022082280; nn) REF EBSI1524, UDI/DI 00653160350784 (case), 10653160350781 (unit), Lot Numbers: 2021122950, 2022082280; oo) REF EBSI1555, UDI/DI 00653160354508 (case), 10653160354505 (unit), Lot Numbers: 2022082280; pp) REF DYNDC3135, UDI/DI 20193489111221 (case), 10193489111224 (unit), Lot Numbers: 2022032180, 2022040480, 2022061380, 2022062080, 2022082280; qq) REF DT22500A, UDI/DI 00653160349795 (case), 10653160349792 (unit), Lot Numbers: 2022020850, 2022050950, 2022061380; rr) REF DYNDC3087, UDI/DI 20193489110477 (case), 10193489110470 (unit), Lot Numbers: 2022013180, 2022020180, 2022020280; ss) REF EBSI1471A, UDI/DI 20193489112600 (case), 10193489112603 (unit), Lot Numbers: 2021121750, 2022020780; tt) REF EBSI1512, UDI/DI 20193489112624 (case), 10193489112627 (unit), Lot Numbers: 2022013180; uu) REF EBSI1546, UDI/DI 00653160352283 (case), 10653160352280 (unit), Lot Numbers: 2022050280; vv) REF EBSI1486, UDI/DI 20193489111184 (case), 10193489111187 (unit), Lot Numbers: 2022041880, 022082280; ww) REF EBSI1523, UDI/DI 00653160349191 (case), 10653160349198 (unit), Lot Numbers: 2021122950, 2022040480; xx) REF DYNDC2703A, UDI/DI 00653160348675 (case), 10653160348672 (unit), Lot Numbers: 2022012480, 2022061380; yy) REF EBSI1434A, UDI/DI 00653160348620 (case), 10653160348627 (unit), Lot Numbers: 2021122150, 2022012480, 2022061380; zz) REF EBSI1525, UDI/DI 00653160349214 (case), 10653160349211 (unit), Lot Numbers: 2021122950; aaa) REF EBSI1525, UDI/DI 00653160350791 (case), 10653160350798 (unit), Lot Numbers: 2021122950; bbb) REF EBSI1208A, UDI/DI 00653160349047 (case), 10653160349044 (unit), Lot Numbers: 2022021480, 2022082280; ccc) REF EBSI1556, UDI/DI 00653160354492 (case), 10653160354499 (unit), Lot Numbers: 2022082280. 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-1117-2024&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-1117-2024&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-1117-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1117-2024 as Class I", "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "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-1117-2024&lang=eng", "value": "Class I", "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-1117-2024&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-1117-2024/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", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1117-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1117-2024", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class I", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "MEDLINE INDUSTRIES, LP - Northfield", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-11-15", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "a) REF CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508; k) DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704; l) DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774; m) DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823; n) DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214; o) DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145; p) DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145; q) DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; r) DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; s) DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574; t) DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607; u) DYNDA2937AH, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 23EBK506, 23FBF438, 23HBN471, 23IBN607 v) REF DYNDC3161, UDI/DI 20193489111627 (case), 10193489111620 (unit), Lot Numbers: 2022031480, 2022061380, 2022082980; w) REF EBSI1530, UDI/DI 00653160354195 (case), 10653160354192 (unit), Lot Numbers: 2022082280; x) REF EBSI1489, UDI/DI 20193489111238 (case), 10193489111231 (unit), Lot Numbers: 2022011350, 2022022880, 2022082280; y) REF EBSI1088A, UDI/DI 20193489111726 (case), 10193489111729 (unit), Lot Numbers: 2022022180; z) REF EBSI1088B, UDI/DI 00653160352689 (case), 10653160352686 (unit), Lot Numbers: 2022061380, 2022082280; aa) REF EBSI1245B, UDI/DI 20193489110828 (case), 10193489110821 (unit), Lot Numbers: 2022031480, 2022082280; bb) REF DYNDC2925B, UDI/DI 00653160349832 (case), 10653160349839 (unit), Lot Numbers: 2022012450, 2022021050, 2022022180; cc) REF EBSI1472A, UDI/DI 20193489112594 (case), 10193489112597 (unit), Lot Numbers: 2021122950, 2022021480; dd) REF EBSI1110C, UDI/DI 00653160352269 (case), 10653160352266 (unit), Lot Numbers: 2022052380; ee) REF EBSI1547, UDI/DI 00653160352276 (case), 10653160352273 (unit), Lot Numbers: 2022050980; ff) REF EBSI1453, UDI/DI 20193489110194 (case), 10193489110197 (unit), Lot Numbers: 2022022180, 2022032880; gg) REF EBSI1476, UDI/DI 20193489110156 (case), 10193489110159 (unit), Lot Numbers: 2022012480, 2022082280; hh) REF EBSI1413A, UDI/DI 20193489112198 (case), 10193489112191 (unit), Lot Numbers: 2022031480; ii) REF EBSI1513, UDI/DI 20193489112617 (case), 10193489112610 (unit), Lot Numbers: 2021122950, 2022012480; jj) REF EBSI1163B, UDI/DI 20193489112112 (case), 10193489112115 (unit), Lot Numbers: 2022050980, 2022061380; kk) REF EBSI1415A, UDI/DI 20193489112235 (case), 10193489112238 (unit), Lot Numbers: 2022021650; ll) REF EBSI1161A, UDI/DI 20193489111801 (case), 10193489111804 (unit), Lot Numbers: 2022012480, 2022022880, 2022082280; mm) REF EBSI1524, UDI/DI 00653160349238 (case), 10653160349235 (unit), Lot Numbers: 2021122950, 2022082280; nn) REF EBSI1524, UDI/DI 00653160350784 (case), 10653160350781 (unit), Lot Numbers: 2021122950, 2022082280; oo) REF EBSI1555, UDI/DI 00653160354508 (case), 10653160354505 (unit), Lot Numbers: 2022082280; pp) REF DYNDC3135, UDI/DI 20193489111221 (case), 10193489111224 (unit), Lot Numbers: 2022032180, 2022040480, 2022061380, 2022062080, 2022082280; qq) REF DT22500A, UDI/DI 00653160349795 (case), 10653160349792 (unit), Lot Numbers: 2022020850, 2022050950, 2022061380; rr) REF DYNDC3087, UDI/DI 20193489110477 (case), 10193489110470 (unit), Lot Numbers: 2022013180, 2022020180, 2022020280; ss) REF EBSI1471A, UDI/DI 20193489112600 (case), 10193489112603 (unit), Lot Numbers: 2021121750, 2022020780; tt) REF EBSI1512, UDI/DI 20193489112624 (case), 10193489112627 (unit), Lot Numbers: 2022013180; uu) REF EBSI1546, UDI/DI 00653160352283 (case), 10653160352280 (unit), Lot Numbers: 2022050280; vv) REF EBSI1486, UDI/DI 20193489111184 (case), 10193489111187 (unit), Lot Numbers: 2022041880, 022082280; ww) REF EBSI1523, UDI/DI 00653160349191 (case), 10653160349198 (unit), Lot Numbers: 2021122950, 2022040480; xx) REF DYNDC2703A, UDI/DI 00653160348675 (case), 10653160348672 (unit), Lot Numbers: 2022012480, 2022061380; yy) REF EBSI1434A, UDI/DI 00653160348620 (case), 10653160348627 (unit), Lot Numbers: 2021122150, 2022012480, 2022061380; zz) REF EBSI1525, UDI/DI 00653160349214 (case), 10653160349211 (unit), Lot Numbers: 2021122950; aaa) REF EBSI1525, UDI/DI 00653160350791 (case), 10653160350798 (unit), Lot Numbers: 2021122950; bbb) REF EBSI1208A, UDI/DI 00653160349047 (case), 10653160349044 (unit), Lot Numbers: 2022021480, 2022082280; ccc) REF EBSI1556, UDI/DI 00653160354492 (case), 10653160354499 (unit), Lot Numbers: 2022082280", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama", "Status": "recorded" } } ] } ] }