FDA Device recall Z-1040-2022
ACS Cath Lab Pack
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of ACS Cath Lab Pack by American Contract Systems, citing product was sterilized with a higher than specification EO concentration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1040-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-22 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
ACS Cath Lab Pack
Reason
Product was sterilized with a higher than specification EO concentration.
Identifiers
| code_info | Model FTCL83K, Lot 982221 UDI: 00191072151360 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1040-2022%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.