Sterile Surgical Packs (American Contract Systems) – Manufacturing Issue (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterile Custom Packs to be used in surgical procedures.
Brand
American Contract Systems Jackson Pointe Commerce
Lot Codes / Batch Numbers
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)
Products Sold
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)
American Contract Systems Jackson Pointe Commerce is recalling Sterile Custom Packs to be used in surgical procedures. due to The surgical gowns were manufactured in a facility that is not registered by the FDA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Recommended Action
Per FDA guidance
Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026