Cath Cardiac Pack, REF IHCC03V
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00191072189431, Lot Numbers: 724221, 679221, 945231
- 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 identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cath Cardiac Pack, REF IHCC03V
Product Codes/Lot Numbers:
UDI/DI 00191072189431, Lot Numbers: 724221, 679221, 945231
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0182-2024
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