Reported Oct 27, 2021 · Ongoing
Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare
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: Stradis Medical, LLC dba Stradis Healthcare · 3025 Northwoods Pkwy · Peachtree Corners, GA · 30071-1524
Is this the product you have?
- Foundation Kit
- Lot codes and dates
- Part NumberA10
- Amount recalled
- 790 kits
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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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