Reported Jan 18, 2023 · Ongoing
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
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?
- Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
- Lot codes and dates
- Assembly Number 570-1130
- UDI-DIH65857011301
- Lot Numbers
222990332222692396222990334221013080222529321220984273222692395222368551220982614222992161
- Amount recalled
- 1,040 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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