Reported Oct 5, 2022 · Ongoing
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For…
Angiodynamics, Inc.
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: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
- Lot codes and dates
- UDI-DI25051684014653
- UPNH787EVLT55OPS5
- Lot Number5728621
- Amount recalled
- 40 units
Where it was sold
Why it was recalled
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
This product could cause temporary or reversible health problems — stop using it.
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