Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION P...
FDA Recall #Z-0819-2024 — Class II — November 29, 2023
Product 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
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.
Recalling Firm
American Contract Systems, Inc. — Temple Terrace, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
290 units
Distribution
US Nationwide distribution.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated