Custom Surgical Packs (American Contract Systems) – Manufacturing Issue (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom Packs to be used in surgical procedures.
Brand
American Contract Systems Jackson Pointe Commerce
Lot Codes / Batch Numbers
WPGA21L, Lot # 998201, Exp. Date 01/02/2021 (24 kits) and Lot # 6781914, Exp date 11/18/2020 (4 kits) AGGL48H, Lot# 643191, Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191, Exp. Date 08/27/2020 (5 kits)
Products Sold
WPGA21L; Lot # 998201, Exp. Date 01/02/2021 (24 kits) and Lot # 6781914, Exp date 11/18/2020 (4 kits) AGGL48H; Lot# 643191, Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191, Exp. Date 08/27/2020 (5 kits)
American Contract Systems Jackson Pointe Commerce is recalling 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