Cardinal Health Presource surgical kits recalled over endotoxin risk
Cardinal Health is recalling about 87,182 Presource procedure kits, including ENT, sinus, nasal, and head and neck kits. The kits contain MEDICOM Ritmed Neurological Sponges that 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 the catalog number and lot number on your Presource kits against the recall list.
- Do not use kits that match the recalled catalog and lot numbers.
- Contact Cardinal Health or your supplier for guidance on returns or replacements, since no remedy is listed yet.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 8 products — see all of them.
Details
- Units affected
- 87182 kits
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, IL, United States
- Classification
- Class II
- Recall number
- Z-2945-2026
In the FDA's words
- Description
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8; Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. 1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 4366 ; 6) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 2390 ; 7) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 265098 ; 8) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7390 ; 9) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7575 ; 10) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 8160 ; 11) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 12) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 13) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 14) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 15) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 16) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 11020 ; 17) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 18) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 19) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 20) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 21) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-1 ; 22) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-2 ; 23) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 9243-1 ; 24) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10339 ; 25) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8160 ; 26) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 11020 ; 27) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 28) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 29) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 30) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 12206 ; 31) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 32) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 33) PE33HNCR1, UDI-DI: 10197106715765(each), 50197106715763(case), Lot Number: 10339 ; 34) PE33HNCR2, UDI-DI: 10197106973325(each), 50197106973323(case), Lot Number: 10586 ; 35) PE33HNCR3, UDI-DI: 10197106997628(each), 50197106997626(case), Lot Number: 11020 ; 36) PE33HNCR4, UDI-DI: 1019895
- 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…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;… (this page)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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