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
4 of 4 products
Products covered by this recall # Product as published 1 AGD1401 2 Lot # 647191, Exp. Date 06/31/2020 (72 kits) and Lot # 685191 Exp. Date 03/31/2020 (6 kits) WPP147H 3 Lot # 684191, Exp. Date 11/12/2020 (20 kits) and Lot # 723191 Exp. Date 10/04/2020 (4 kits) SVOH38N 4 Lot # 654191, Exp. Date 12/12/2020 (32 kits) - Amount recalled
- 2868 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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