Reported Jun 10, 2020 · Terminated
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems · Jackson Pointe Commerce · Zelienople, PA · 16063-2838
Is this the product you have?
- Sterile Custom Packs to be used in surgical procedures.
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 WPPP52E 2 Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M 3 Lot # 656191, Exp. Date 12/10/2020 (20 kits) VSMI14G 4 Lot # 643191, Exp. Date 12/23/2020 (60) and Lot #71891, Exp. Date 10/09/2020 (6 kits) WXOLO48H 5 Lot # 654191, Exp. Date 12/12/2020 (6 kits) AGKD5OJ 6 Lot # 997201, Exp. Date 01/03/2021 (26 kits) AGME44J 7 Lot # 997201, Exp. Date 01/03/2021 (24 kits) AGMA31K 8 Lot # 642191, Exp. Date 12/24/2020 (96 kits) AGMI141 9 Lot # 671191, Exp. Date 11/25/2020 (36 kits) and Lot # 789191, Exp. Date 07/30/2020 (14 kits) AVMA31I 10 Lot # 675191, Exp. Date 11/21/2020 (2 kits) AVMI14H 11 Lot # 639191, Exp. Date 12/27/2020 (70 kits) WXMI14H 12 Lot # 650191, Exp. Date 12/16/2020 (160 kits) AGLO48H 13 Lot # 670191, Exp. Date 11/26/2020 (30 kits) SVMA21I 14 Lot # 654191, Exp. Date 12/12/2020 (30 kits) - Amount recalled
- 2,868 kits
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
- PA
Why it was recalled
The surgical gowns were manufactured in a facility that is not registered by the FDA.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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