FDA Device recall Z-1693-2022
Various ENT Packs
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Various ENT Packs by American Contract Systems, citing product was exposed to multiple sterilization cycles without validation for multiple exposures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1693-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-16 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | AZ, FL, IA, IL, MA, MN, MO, NE, OH, PA, RI, SD, TX |
Product
Various ENT Packs
Reason
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Identifiers
| code_info | Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2…Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2104262, 887211, 14934943 3) COEN27K, 2108102, 779211, 15093749-004 |
|---|
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-1693-2022%22
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