Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO
FDA recall Z-2993-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO (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-2993-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO
The FDA logged enforcement record Z-2993-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO — 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-RDF036O, Lot Number 24BMG670; 00-RDF036OH, Lot Number 24BMG670; 00-RDF036OH, Lot Number 22FMH197 ; 00-RDF036OH, Lot Number 22IMC476 ; 00-RDF036OH, Lot Number 22JMD690 ; 00-RDF036OH, Lot Number 22KMB816 ; 00-RDF036OH, Lot Number 22LMB962 ; 00-RDF036OH, Lot Number 23BMA905 ; 00-RDF036OH, Lot Number 23BMH681 ; 00-RDF036OH, Lot Number 23CMG412 ; 00-RDF036OH, Lot Number 23DMI750 ; 00-RDF036OH, Lot Number 23IMD552 ; 00-RDF036OH, Lot Number 23KMD849 ; 0M-CP31433J, Lot Number 24DBD373; ART1210, Lot Number 2023121890; BM17BAD, Lot Number 22FBA406; BM17BAD, Lot Number 22EBJ428; CVI4970, Lot Number 2023121880; DYNDH1129, Lot Number 2019012450; DYNDH1134, Lot Number 2019012450; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1228, Lot Number 23JBW148; DYNDH1228, Lot Number 23HBW751; DYNDH1228, Lot Number 23FBU652; DYNDH1228, Lot Number 23DBK822; DYNDH1540A, Lot Number 2023091990; DYNDH1827, Lot Number 24BMB809; DYNDH1932, Lot Number 2023121180; DYNDL1462B, Lot Number 2019012450; DYNJ0105963Q, Lot Number 22GMH630; DYNJ0105963Q, Lot Number 22EMG581; DYNJ0105963Q, Lot Number 22CMI727; DYNJ0105963Q, Lot Number 22CMA702; DYNJ0161912G, Lot Number 23KDB964; DYNJ0173400P, Lot Number 21FMC951; DYNJ0173400P, Lot Number 21DME907; DYNJ0173400P, Lot Number 21CMB877; DYNJ0173400P, Lot Number 21AMB468; DYNJ0173400P, Lot Number 20LME686; DYNJ0173400P, Lot Number 20LMC387; DYNJ0173400P, Lot Number 20JMC557; DYNJ0173400P, Lot Number 20IMB398; DYNJ0173400P, Lot Number 20GMC663; DYNJ0173400P, Lot Number 20EMA806; DYNJ0173400P, Lot Number 20EMA459; DYNJ0173400P, Lot Number 20BBR274; DYNJ0194968AG, Lot Number 24CMC638; DYNJ0194968AG, Lot Number 24BME100; DYNJ0275614F, Lot Number 24CMD821; DYNJ0275614F, Lot Number 24AMJ414; DYNJ0429201L, Lot Number 24BMI261; DYNJ04386U, Lot Number 24CMF538; DYNJ04562S, Lot Number 23BLA247; DYNJ04562S, Lot Number 23ALA434; DYNJ04562S, Lot Number 23ALA227; DYNJ04562S, Lot Number 22KLA758; DYNJ04562S, Lot Number 22KLA141; DYNJ04562S, Lot Number 22JLA659; DYNJ04562S, Lot Number 22ILA617; DYNJ04562S, Lot Number 22GLA997; DYNJ04674U, Lot Number 24BMJ236; DYNJ04674U, Lot Number 24BMB067; DYNJ04674UH, Lot Number 24BMJ236; DYNJ04674UH, Lot Number 24BMB067; DYNJ04674UH, Lot Number 23DMF209 ; DYNJ04674UH, Lot Number 23EMJ411 ; DYNJ04674UH, Lot Number 23FMD591 ; DYNJ04674UH, Lot Number 24AMB874 ; DYNJ0490280PH, Lot Number 21HMD962 ; DYNJ0490280PH, Lot Number 21JMH929 ; DYNJ0490280PH, Lot Number 19AKC431 ; DYNJ0490280PH, Lot Number 21KME862 ; DYNJ0490280PH, Lot Number 19BKB887 ; DYNJ0490280PH, Lot Number 19DKA387 ; DYNJ0490280PH, Lot Number 22AMB750 ; DYNJ0490280PH, Lot Number 22BMB089 ; DYNJ0490280PH, Lot Number 22CMF731 ; DYNJ0490280PH, Lot Number 22DME928 ; DYNJ0490280PH, Lot Number 22FMG329 ; DYNJ0490280PH, Lot Number 22HMG030 ; DYNJ0490280PH, Lot Number 22JMC980 ; DYNJ0490280PH, Lot Number 22LME104 ; DYNJ0490280PH, Lot Number 23AMB149 ; DYNJ0490280PH, Lot Number 23BMH102 ; DYNJ0490280PH, Lot Number 23EMG454 ; 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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-2993-2024 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.
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DYNJ65238B, Lot Number 22EMF834; DYNJ65238B, Lot Number 22BMG103; DYNJ65481, Lot Number 24BMJ722; DYNJ65481, Lot Number 24BMF056; DYNJ65578A, Lot Number 24BMJ184;