CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Exp: 07/30/2025; 71-051767, Exp: 08/14/2025; 71-053065, Exp: 12/10/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- American Contract Systems Inc
- Reason for Recall:
- During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Product Codes/Lot Numbers:
Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Exp: 07/30/2025; 71-051767, Exp: 08/14/2025; 71-053065, Exp: 12/10/2025
Distribution:
Distributed in: US, MI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1406-2025
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