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
11 of 11 products
Products covered by this recall # Product as published 1 WXCT12E 2 Lot # 998201, Exp. Date 001/02/2021 (70 kits) PTHS10C 3 Lot # 664191, Exp. Date 12/02/2020 (2 kits) AVHA64H 4 Lot # 663191, Exp. Date 12/06/2020 (30 kits) WXPO16G 5 Lot # 639191, Exp. Date 12/27/2020 (26 kits) and Lot # 689191, Exp. Date 11/07/2020 (6 kits) VSSA12G 6 Lot # 646191, Exp. Date 12/20/2020 (12 kits) AGBA20H: Lot 3 970191, Exp. Date 01/30/20 (2 kits) WXSA12H 7 Lot # 653191, Exp. Date 12/13/2020 (40 kits) WXKA26H 8 Lot # 981201, Exp. Date 01/19/2021 (18 kits) and Lot # 639191, Exp. Date 12/27/2020 (32 kits) WXHA64H 9 Lot # 682191, Exp. Date 11/14/2020 (18 kits) 10 Lot # 636191, Exp. Date 12/30/2020 (121 kits) and Lot # 684191, Exp. Date 11/12/2020 (6 kits) AGKA26H 11 Lot # 992201, Exp. Date 01/08/2021 (64 kits) - Amount recalled
- 2,8,68 total 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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