Z-2681-2020 Class II Terminated
FDA device recall Z-2681-2020 was initiated by Boston Scientific Corporation on June 4, 2020 and is designated Class II. Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure. The recall status is terminated (terminated September 23, 2024). Affected quantity: 71 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 4, 2020
- Termination Date
- September 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 devices
Product Description
Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Reason for Recall
The needle surface deteriorated due to unexpected electrolysis during procedure.
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.
Code Information
UPN:FPRPR3608, GTIN: 7290104831065, Batch: A1170, A1583, A1937, A6710, A6744, A6857, A6900, A6913, A6926, A7014, A7027, A7122, T0055, T0144, T0181, T0211, T0212, T0238, T0270, T0816, T0815