Reported Jan 18, 2023 · Ongoing
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
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 Healthcare · 3600 Burwood Dr · Waukegan, IL · 60085-8399
Is this the product you have?
- Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
- Lot codes and dates
- a. Assembly Number 33066
- UDI-DIM752330661
- Lot Numbers
222782334222519530222438660b. Assembly Number 33068
- UDI-DIM752330681
- Lot Numbers
222145412220551558222508466
- Amount recalled
- 920 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
Potential for the outer bag having pinhole leaks near the seal, 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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