FDA Medical Device Recalls (openFDA)
American Contract Systems: Sterile Custom Packs to be used in surgical procedures.
- Recall number
- Z-2166-2020
- 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
- 2,868 surgical kits total
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Lot, serial or model codes
- ACS Tray Numbers: SVOH98F; Lot # 676191, Exp. date 11/20/20 (3 kits) AHMV261; Lot # 676191, Exp. date 11/20/20 (10 kits) AGMV26L: Lot # 688191, Exp. date 11/08/2020 (36 kits) FBTO60G: Lot # 635191, Exp. date 12/31/2020 (25 kits) FBTO60G: Lot # 711191, Exp. date 10/16/2020 (3 kits) AGEP48G: Lot # 991201, Exp. date 01/09/2021 (72 kits) AGBR90D: Lot # 843191, Exp. date 06/06/2020 (48 kits) AGTP52J: Lot # 643191, Exp. date 12/23/2020 (42 kits) AGTP52J: Lot # 716191, Exp. date 10/11/2020 (8 kits)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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