Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) K
Cardinal Health 200, LLC
The hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) 21-4720BModel UDI-DI: 10888439934663(each)Model 50888439934661(case)Model Lot Number: 94970Model 2) 21-4720CModel UDI-DI: 10197106675793(each)Model 50197106675791(case)Model Lot Number: 10339Model 3) 21-4720CModel Lot Number: 10586Model 4) PECGMLBOBModel UDI-DI: 10197106067406(each)Model 50197106067404(case)Model Lot Number: 4366Model 5) PECGNAAU8Model UDI-DI: 10197106967706(each)Model 50197106967704(case)Model Lot Number: 12206Model 6) PECGNAAUJModel UDI-DI: 10197106894514(each)Model 50197106894512(case)Model Lot Number: 11851Model 7) PN1DTSLH9UPC 10888439934663UPC 50888439934661UPC 10197106675793UPC 50197106675791UPC 10197106067406UPC 50197106067404UPC 10197106967706UPC 50197106967704UPC 10197106894514UPC 50197106894512UPC 10198956120051UPC 50198956120059UPC 10197106492222UPC 50197106492220UPC 10197106660195UPC 50197106660193Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.