Medical Device Recall: Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
American Contract Systems, Inc. · November 29, 2023
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.
States Affected
NATIONWIDE
Quantity Affected
95 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0821-2024
Status: ongoing
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