FDAFDA · Food and drugs·Recall number Z-0917-2025

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;

Published January 22, 2025 · Recall initiated: November 8, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Cardinal Health 200, LLC
Distributor: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Lot: Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number J43U76 ; Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number J43U77 ; Catalog Number PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS), Lot Number J34J42 ; Catalog Number PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS), Lot Number J8124C ; Catalog Number PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS), Lot Number 5478802 ; Catalog Number PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS), Lot Number 6702010 ; Catalog Number PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS), Lot Number 6928766 ; Catalog Number PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS), Lot Number 7280108 ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J53W73 ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J5679J ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J5679D ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J6050D ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J5679K ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J5679K ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J74A31 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6596396 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J8671P ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J6050H ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5135997 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5533333 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J70X17 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5664099 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5140345 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5664103 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5891308 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5891307 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J6367H ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6025791 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number L00302 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6560945 ; Catalog Number PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS), Lot Number 6702009 ; Catalog Number PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS), Lot Number 6928770 ; Catalog Number SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS), Lot Number 6914944 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6022130 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6702009 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6806115 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6806114 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 6928759 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429
Risk classification: Class II
Area (FDA): device
Country: United States

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