Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO
FDA recall Z-2992-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO (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.
openFDA drug & device enforcement (recall) reports
FDA recall Z-2992-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO
The FDA logged enforcement record Z-2992-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO — 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: 00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB825 ; 00-398712S , Lot Number 21JMH910 ; 00-398712S , Lot Number 21LMG148 ; 00-398712S , Lot Number 22BMH320 ; 00-398712S , Lot Number 22DME594 ; 00-398712S , Lot Number 22HMI166 ; 00-398712S , Lot Number 22JME059 ; 00-398712S , Lot Number 23AME236 ; 00-398712S , Lot Number 23DME416 ; 00-398712S , Lot Number 23FMG905 ; 00-398712S , Lot Number 23IMF984 ; 00-398712S , Lot Number 23KMF990 ; 00-398712S , Lot Number 19BKB212 ; 00-398712S , Lot Number 19CKB198 ; 00-398712S , Lot Number 19EKB257 ; 00-398712S , Lot Number 19GKC485 ; 00-398712S , Lot Number 19IKA568 ; 00-398712S , Lot Number 19IKB991 ; 00-398725AM, Lot Number 21FBJ550 ; 00-398725AM, Lot Number 19IBJ529 ; 00-398725AM, Lot Number 19KBS571 ; 00-398725AM, Lot Number 19KBU397 ; 00-398725AM, Lot Number 20BBE698 ; 00-398725AM, Lot Number 20CBG353 ; 00-398725AM, Lot Number 20DBI198 ; 00-398725AM, Lot Number 20FBB296 ; 00-398725AM, Lot Number 20FBC302 ; 00-398725AM, Lot Number 20GBF723 ; 00-398725AM, Lot Number 20HBM698 ; 00-398725AM, Lot Number 20LBR908 ; 00-398725AM, Lot Number 21BBE202 ; 00-398725AM, Lot Number 21DBD638 ; 00-399360K , Lot Number 21VBC685 ; 00-399360K , Lot Number 23FBU384 ; 00-399360K , Lot Number 23IBA381 ; 00-399360K , Lot Number 23KBE043 ; 00-399360K , Lot Number 23LBR853 ; 00-399734N , Lot Number 23JBU818 ; 00-399734N , Lot Number 23KBI990 ; 00-399734N , Lot Number 23LBV170 ; 00-399734N , Lot Number 19ADB519 ; 00-399734N , Lot Number 19BDB357 ; 00-399734N , Lot Number 19DDA161 ; 00-399734N , Lot Number 19EDA281 ; 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A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
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.
FDA classified recall Z-2992-2024 as Class II
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.
U.S. FDA recall classification (openFDA enforcement)
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.
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.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
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.
Ongoing — the recall is still being carried out.
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.