🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 8, 2024 Cardinal Health 200 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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 ;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
Reason for Recall:
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0911-2025

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Cardinal Health 200

Class I - Dangerous

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

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Cardinal Health 200

Class I - Dangerous

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Cardinal Health 200

Class I - Dangerous

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

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