Z-1153-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- February 1, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5894 units
Product Description
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Reason for Recall
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Distribution Pattern
US Nationwide distribution in the states of CA and FL.
Code Information
Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).