Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Reason for recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 information
- Catalog #
- PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS)
- Lot #
- J43U76
- Catalog #
- PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS)
- Lot #
- J43U77
- Catalog #
- PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS)
- Lot #
- J34J42
- Catalog #
- PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS)
- Lot #
- J8124C
- Catalog #
- PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS)
- Lot #
- 5478802
- Catalog #
- PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS)
- Lot #
- 6702010
- Catalog #
- PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS)
- Lot #
- 6928766
- Catalog #
- PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS)
- Lot #
- 7280108
- Catalog #
- PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS)
- Lot #
- J53W73
- Catalog #
- PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS)
- Lot #
- J5679J
- Catalog #
- PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS)
- Lot #
- J5679D
- Catalog #
- PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS)
- Lot #
- J6050D
- Catalog #
- PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS)
- Lot #
- J5679K
- Catalog #
- PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS)
- Lot #
- J5679K
- Catalog #
- PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS)
- Lot #
- J74A31
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 6596396
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- J8671P
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- J6050H
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5135997
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5533333
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- J70X17
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5664099
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5140345
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5664103
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5891308
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 5891307
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- J6367H
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 6025791
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- L00302
- Catalog #
- PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS)
- Lot #
- 6560945
- Catalog #
- PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS)
- Lot #
- 6702009
- Catalog #
- PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS)
- Lot #
- 6928770
- Catalog #
- SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS)
- Lot #
- 6914944
- Catalog #
- SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS)
- Lot #
- 6022130
- Catalog #
- SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS)
- Lot #
- 6702009
- Catalog #
- SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS)
- Lot #
- 6806115
- Catalog #
- SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS)
- Lot #
- 6806114
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 6928759
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 6928766
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 7280107
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 5
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 7280109
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 7331341
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 7332916
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 6928772
- Catalog #
- SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS)
- Lot #
- 7332907
- Catalog #
- SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS)
- Lot #
- 7332905
- Catalog #
- SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS)
- Lot #
- 6928770
- Catalog #
- SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS)
- Lot #
- J8692Y
- Catalog #
- SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS)
- Lot #
- 6702010
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J37U06
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J31U58
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J46C00
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J4952D
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J5679A
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J53W68
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- N/A
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J5679K
- Catalog #
- SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS)
- Lot #
- J84K02
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 2300125464
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6563992
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6702010
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6928758
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6928759
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6928764
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 7163103
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 7280105
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 7332904
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6928770
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 7332918
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- J86T81
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5135984
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5140348
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5405626
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5533334
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5664098
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5747232
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5891307
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5891305
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 5891313
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6022133
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6022130
- Catalog #
- SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS)
- Lot #
- 6264567
Show 156 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0917-2025
- FDA device classification · OJKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.4790The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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