FDA Device recall Z-2521-2024
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Tot…
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Tot… by American Contract Systems, citing product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2521-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-06 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Reason
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Identifiers
| code_info | (1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 0019107220112…(1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 00191072201126; Lot 988241;Exp. Date 1/12/2025; (3) Model No CETJ13O; UDI-DI 00191072202017; Lot 989241;Exp. Date 1/11/2025. |
|---|
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-2521-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.