| | Class 2 Device Recall Cardinal Health Presource Kits |  |
| Date Initiated by Firm | November 08, 2024 |
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| Date Posted | January 15, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0911-2025 |
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| Recall Event ID |
95722 |
| Product Classification |
General purpose dental tray - Product Code OFX
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| 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 |
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| Code Information |
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 ;
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| FEI Number |
3001236905
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Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
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| For Additional Information Contact | Cardinal Health Quality Systems
800-292-9332 |
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Manufacturer Reason
for Recall | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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. |
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| Quantity in Commerce | 512,786 total units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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