FDA Device recall Z-0821-2024
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A by American Contract Systems, citing 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 doc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0821-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-29 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Reason
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.
Identifiers
| code_info | AHBP12A, UDI/DI 00191072188229, Lot Numbers: 963231, exp. 1/21/2024; 940231, exp. 1/21/2024; 996231, exp. 2/28/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0821-2024%22
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