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;;
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- November 8, 2024
- Posted
- January 15, 2025
- Recall Number
- Z-0917-2025
- Quantity
- 512,786 total units
- Firm Location
- Waukegan, IL
Reason for Recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Lot / Code Info
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 (EA)50197106431427 (CS), Lot Number 6928766 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7280107 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 5 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7280109 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7331341 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7332916 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 6928772 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7332907 ; Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number 7332905 ; Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number 6928770 ; Catalog Number SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS), Lot Number J8692Y ; Catalog Number SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS), Lot Number 6702010 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J37U06 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J31U58 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J46C00 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J4952D ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J5679A ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J53W68 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number N/A ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J5679K ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J84K02 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 2300125464 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6563992 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6702010 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928758 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928759 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928764 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7163103 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7280105 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7332904 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928770 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7332918 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number J86T81 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5135984 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5140348 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5405626 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5533334 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5664098 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5747232 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891307 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891305 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891313 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6022133 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6022130 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6264567 ;
Root Cause
Nonconforming Material/Component
Action Taken
An URGENT: PRODUCT RECALL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. REVIEW your inventory immediately stop using the affected product code and lots attached. 2. COMMUNICATE with all personnel who utilize the Presource Kits containing CODMAN Patties & Strips component produced by Integra LifeSciences. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product or to whom you plan to send the product about this medical device product correction and share a copy of this notice. 1. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. For Presource kit credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits, please notify your customers of this recall. In the event you have experienced quality problems or adverse events related to the products listed above, please utilize the contacts above to report the event. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.