Z-0680-2021 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
- 1,526 units
Product Description
IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3194 UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280 Batch Numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954