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.
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. Distribution: US Nationwide distribution. Quantity: 144 units Lot/code info: a) BBLV21C, UDI/DI none, Lot Numbers: 686221, exp. 11/10/2023; 791221, exp. 7/28/2023; 841221, exp. 6/8/2023; b) BFHY75U, UDI/DI 00191072169839, Lot Numbers: 878231, exp. 5/2/2024; 933231, exp. 3/8/2024; 987231, exp. 11/30/2023; 659221, exp. 12/7/2023; 689221, exp. 11/7/2023
00191072169839
Official record: FDA (Device enforcement) ↗
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