FDA Medical Device Recalls (openFDA)
American Contract Systems: Sterile Custom Packs to be used in surgical procedures.
- Recall number
- Z-2171-2020
- Recalling firm
- American Contract Systems
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Status
- Terminated
- Initiated
- 2020-04-13
- Posted
- not on file
- Terminated
- 2020-11-25
- Reason
- The surgical gowns were manufactured in a facility that is not registered by the FDA.
- Root cause
- Process control
- Action
- Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
- Quantity
- 2868 total kits
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Lot, serial or model codes
- ACS Tray Numbers: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 kits)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEQ
- Firm FEI
- 3011389083
- Firm city
- Zelienople
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28