Z-0665-2021 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
- 262 units
Product Description
IceRod" 1.5 i-Thaw" Cryoablation Needle
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329