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
9 of 9 products
Products covered by this recall # Product as published 1 Lot # 676191, Exp. date 11/20/20 (3 kits) AHMV261 2 Lot # 676191, Exp. date 11/20/20 (10 kits) AGMV26L 3 Lot # 688191, Exp. date 11/08/2020 (36 kits) FBTO60G 4 Lot # 635191, Exp. date 12/31/2020 (25 kits) FBTO60G 5 Lot # 711191, Exp. date 10/16/2020 (3 kits) AGEP48G 6 Lot # 991201, Exp. date 01/09/2021 (72 kits) AGBR90D 7 Lot # 843191, Exp. date 06/06/2020 (48 kits) AGTP52J 8 Lot # 643191, Exp. date 12/23/2020 (42 kits) AGTP52J 9 Lot # 716191, Exp. date 10/11/2020 (8 kits) - Amount recalled
- 2,868 surgical kits total
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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