FDA Device recall Z-2171-2020
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-2171-2020 |
| 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: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 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-2171-2020%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.