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
- ACS Tray NumbersFBCS38I; Lot # 692191, Exp. Date 11/04/2020 (4 kits) and Lot # 648191,Exp. Date 12/18/2020 (40 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.
Want the full recall guide?
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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