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
8 of 8 products
Products covered by this recall # Product as published 1 AGTA481 2 Lot # 998201, Exp. Date 01/02/2021 (60 kits) WXEN11G 3 Lot # 994201, Exp. Date 01/06/2021 (32 kits) VSMT20G 4 Lot # 677191, Exp. Date 11/19/2020 (12 kits) AGHN20J 5 Lot # 636191, Exp. Date 12/30/2020 (4 kits) 6 Lot # 675191, Exp. Date 11/21/2020 (12 kits) and Lot # 741191, Exp. Date 09/16/2020 (36 kits) AGEN11H 7 Lot # 657191, Exp. Date 12/09/2020 (66 kits) VSEN11F 8 Lot # 664191, Exp. Date 12/02/2020 (8 kits) - Amount recalled
- 2868 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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