Cardinal Health Presource kits recalled for endotoxin variability
Cardinal Health is recalling about 36,862 Presource procedure kits, across many catalog numbers and lot numbers. The kits contain MEDICOM Ritmed Neurological Sponges, which were recalled because their endotoxin levels vary unexpectedly. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Check your kits' catalog and lot numbers against the recall notice.
- Set aside any affected kits and do not use them until you get guidance.
- Contact Cardinal Health for instructions on affected kits, since no remedy has been specified.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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 ,
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 8 products — see all of them.
Details
- Units affected
- 36862 kits
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, IL, United States
- Classification
- Class II
- Recall number
- Z-2942-2026
In the FDA's words
- Description
- 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 , Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. 1) 21-4720B, UDI-DI: 10888439934663(each), 50888439934661(case), Lot Number: 94970 ; 2) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10339 ; 3) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10586 ; 4) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 4366 ; 5) PECGNAAU8, UDI-DI: 10197106967706(each), 50197106967704(case), Lot Number: 12206 ; 6) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 11851 ; 7) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14813 ; 8) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14039 ; 9) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 8160-1 ; 10) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 3747 ; 11) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 12) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 13) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 14) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 15) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 16) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 17) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 13289 ; 18) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 19) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 20) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 21) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 22) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10586 ; 23) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106
- Hazard
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
8 products in this recall
Cardinal Health Presource kits recalled for endotoxin variability
Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3… (this page)Z-2942-2026 · 36862 kits
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCCZ-2943-2026 · 456 kits
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBZ-2944-2026 · 80 kits
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA;…Z-2945-2026 · 87182 kits
- Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE…Z-2946-2026 · 602 kits
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28…Z-2947-2026 · 401311 kits
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4…Z-2948-2026 · 52699 kits
- Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPH…Z-2949-2026 · 616 kits
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