Reported Dec 21, 2022 · Ongoing
HENRY SCHEIN, GYN PACK, Item No.570-2625
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?
- HENRY SCHEIN, GYN PACK, Item No.570-2625
- Lot codes and dates
UDI/DI (case) H65857026251UDI/DI (kit)M75257026250
- Serial/Lot Numbers22230491067
- Amount recalled
- 20 units
This recall covers 78 products
The agency filed one notice per product. You are reading one of them; the other 77 are below.
65 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
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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