FDA Device recall Z-2176-2020
Sterile Custom Packs to be used in surgical procedures
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of Sterile Custom Packs to be used in surgical procedures by American Contract Systems, citing the surgical gowns were manufactured in a facility that is not registered by the FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2176-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-13 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Sterile Custom Packs to be used in surgical procedures.
Reason
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Identifiers
| code_info | ACS Tray Numbers: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020…ACS Tray Numbers: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020 (2 kits) AHLA17J; Lot # 653191, Exp. Date 12/13/2020 (12 kits) SVNE16K; Lot # 691191, Exp. Date 11/05/2020 (20 kits) WPLA17I; Lot # 685191, Exp. Date 11/11/2020 (2 kits) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2176-2020%22
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