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Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N F...

FDA Device Recall #Z-0917-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0917-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

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;;

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

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 ;

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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