Reported Sep 4, 2019 · Terminated
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding…
Leventon S. A. U.
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: Leventon S. A. U. · Calle Newton 18 24 · Barcelona, N/A · N/A
Is this the product you have?
- DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
- Lot codes and dates
- 172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
- Amount recalled
- 1700
Where it was sold
Why it was recalled
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
This product could cause temporary or reversible health problems — stop using it.
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