Sterile Custom Packs to be used in surgical procedures.
Hazard
The surgical gowns were manufactured in a facility that is not registered by the FDA.
What You Should Do
Remedy
Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
Affected by this recall?
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Products
Sterile Custom Packs to be used in surgical procedures.
- Brand
- American Contract Systems Jackson Pointe Commerce
- UPC
- 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)
Units Affected
2,868 surgical kits total