Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) LLCE52, UDI/DI 00191072030832, Lot Numbers: 912231, exp. 11/30/2023; b) UICL44N, UDI/DI 00191072142696, Lot Numbers: 991231, exp. 1/9/2024; 891231, exp. 1/30/2024 c) UIPL77K, UDI/DI 00191072142801, Lot Numbers: 748221, exp. 9/9/2023; 650221, exp. 12/16/2023; 919231, exp. 3/22/2024
- 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 several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had 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:
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
Product Codes/Lot Numbers:
a) LLCE52, UDI/DI 00191072030832, Lot Numbers: 912231, exp. 11/30/2023; b) UICL44N, UDI/DI 00191072142696, Lot Numbers: 991231, exp. 1/9/2024; 891231, exp. 1/30/2024 c) UIPL77K, UDI/DI 00191072142801, Lot Numbers: 748221, exp. 9/9/2023; 650221, exp. 12/16/2023; 919231, exp. 3/22/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0819-2024
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