Z-0690-2021 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
- 178 units
Product Description
Five IceRod" i-Thaw" Prostate Cryoablation Kit
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252