Class II Recall

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

Summary

The FDA issued a Class II for Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAM by Cardinal Health 200, LLC. Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits..

Details

Source

Device Recall

External ID

Z-0917-2025

Action Date

2025-01-22

Status

Ongoing

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;;

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 ;

Quantity Affected: 512,786 total units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-11-08

Company

Cardinal Health 200, LLC

Waukegan, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 249 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Cardinal Health 200, LLC have FDA actions?

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0917-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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