Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving potential endotoxin contamination (a high-risk biological hazard) in sterile surgical supplies. The theoretical hazard with no reported illnesses or injuries meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource surgical kits and dental packs due to potential endotoxin contamination in the non-sterile surgical strips and patties included in these kits. The contamination risk affects approximately 512,786 units distributed worldwide, including the United States, Canada, and Saudi Arabia.
The affected products include three catalog variations: the Major Oral Surgery Kit (PGDHMOWOE), and two ORP Dental Pack variants (SENHDDPVCH and SENHDDPVCI). Multiple lot numbers for each product have been identified by the manufacturer.
Endotoxin is a bacterial substance that can cause serious adverse reactions when present in surgical supplies, particularly during surgical procedures. Customers who have received affected units should discontinue use and contact Cardinal Health 200, LLC for return or replacement instructions.
Healthcare facilities and practitioners should verify their inventory against the identified lot numbers and prevent the use of potentially contaminated supplies.
The recalled product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- endotoxin-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number PGDHMOWOE
- UDI/DI 10888439587074 (EA)50888439587072 (CS)
- Lot Number J1896M
- Lot Number J3987C
- Lot Number J43U76
- Lot Number J46C02
- Lot Number J4952G
- Lot Number J74A30
- Lot Number J8064Z
- Lot Number J8123Z
- Lot Number J84K03
- Catalog Number SENHDDPVCH
- UDI/DI 10195594888015 (EA)50195594888013 (CS)
- Lot Number 22D1239
- Lot Number 21K3110
- Catalog Number SENHDDPVCI
- UDI/DI 10197106474570 (EA)50197106474578 (CS)
- Lot Number 23J2297
- Lot Number 23F1430
- Lot Number 24C0657
Distribution
Distributed nationwide across the United States.
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