FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
- Recall number
- Z-0911-2025
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
- Status
- Open, Classified
- Initiated
- 2024-11-08
- Posted
- 2025-01-15
- Terminated
- not on file
- Reason
- Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 512,786 total units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Lot, serial or model codes
- Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J1896M ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J3987C ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J43U76 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J46C02 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J4952G ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J74A30 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8064Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8123Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J84K03 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 24C0657 ;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFX
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28