FDA Device recall Z-2178-2020
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-2178-2020 |
| 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: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kit…ACS Tray Numbers: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kits) AGHA64J; Lot # 663191, Exp. Date 12/03/2020 (72 kits) and Lot # 716191, Exp. Date 10/11/2020 (10 kits) WPBU64H; Lot # 670191, Exp. Date 11/26/2020 (16 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-2178-2020%22
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