Z-0677-2021 Class II
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 18, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 525 units
Product Description
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3506 UDIs: 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594 Batch Numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374