Z-0678-2021 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
- 3,894 units
Product Description
IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3195 UDIs: 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297 Batch Numbers: U1406, U1407, U1370, U1369, U1041, U1042, U0611, U0610, U0501, U0419, U0447, U0444, U0418, U0322, U0323, U0211, U0243, U0244, U0208, U0209, U0210, U0189, U0188, U0175, U0174, U0031, U0164, U0005, U0004, U0002, U0001, T0786, T0785, T0664, T0665, T0649, T0650, T0562, T0561, T0452, T0451, T0445, T0441, T0440, T0364, T0365, T0361, T0360, T0192, T0193, T0179, T0180, A7213, A6715, A6714, A6712, A6711, A6672, A6673, A2093, A2094, A2036, A2037, A2023, A2024, A2011, A2012, A1986, A1987, A1949, A1948, A1944, A1943, A1925, A1924, A1884, A1883, A1839, A1837, A1838, A1832, A1833, A1758, A1759, A1756, A1757, A1648, A1647, A1572, A1573, A1555, A1556, A1534, A1334, A1321, A1322, A1318, A1319, A1200, A1198, A1201, A1199, A1070, A1071, A1068, A1067, A1002, A1001, A0882, A0883, A0878, A0879, A0737, A0738