Device product
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Z-2683-2020
Product summary
- Event
- Event 85815
- Status
- Terminated
- Classification
- Class II
- Quantity
- 656 devices
- Official record key
device-enforcement:Z-2683-2020
Official wording
Reason: The needle surface deteriorated due to unexpected electrolysis during procedure.
Code information: UPN: FPRPR3618 , GTIN: 07290104831089, Batch: X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161
Distribution pattern: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
Derived failure modes
-
Unknown
The needle surface deteriorated due to unexpected electrolysis during procedure.