FDA Device recall Z-2170-2020
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-2170-2020 |
| 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: WPPP52E; Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M; Lot # 656191, Exp. Date 12/10/2020…ACS Tray Numbers: WPPP52E; Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M; Lot # 656191, Exp. Date 12/10/2020 (20 kits) VSMI14G; Lot # 643191, Exp. Date 12/23/2020 (60) and Lot #71891, Exp. Date 10/09/2020 (6 kits) WXOLO48H; Lot # 654191, Exp. Date 12/12/2020 (6 kits) AGKD5OJ; Lot # 997201, Exp. Date 01/03/2021 (26 kits) AGME44J; Lot # 997201, Exp. Date 01/03/2021 (24 kits) AGMA31K; Lot # 642191, Exp. Date 12/24/2020 (96 kits) AGMI141; Lot # 671191, Exp. Date 11/25/2020 (36 kits) and Lot # 789191, Exp. Date 07/30/2020 (14 kits) AVMA31I; Lot # 675191, Exp. Date 11/21/2020 (2 kits) AVMI14H; Lot # 639191, Exp. Date 12/27/2020 (70 kits) WXMI14H; Lot # 650191, Exp. Date 12/16/2020 (160 kits) AGLO48H; Lot # 670191, Exp. Date 11/26/2020 (30 kits) SVMA21I; Lot # 654191, Exp. Date 12/12/2020 (30 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-2170-2020%22
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