Z-1819-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
Code Information
UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621