Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUND...
FDA Recall #Z-0816-2024 — Class II — November 29, 2023
Product Description
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
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
182 units
Distribution
US Nationwide distribution.
Code Information
a) LMHA01V: No UDI/DI, Lot Numbers: 702221, exp. 10/25/223; 654221, exp. 12/12/2023; 954231, exp. 2/15/2024; 903231, exp. 4/7/2024; b) UIAN43L: No UDI/DI, Lot Numbers: 654221, exp. 12/12/2023; 991231, exp. 1/9/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated