Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 193 units of Galil Medical's 2.1 CX Cryoablation Needles used with the IcePearl 2.1 CX Prostate Kit Visual Ice System. The needles, which are prescription-only medical devices intended for cryoablative procedures, were recalled because the needle surface deteriorated due to unexpected electrolysis during use. The affected devices were distributed nationwide across all U.S. states and Canada, spanning multiple lot numbers from A1148 through U0227.
The recall notice does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure. Distribution: 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. Quantity: 193 devices Lot/code info: UPN:FPRPR3606, GTIN: 7290104831041, Batch: A1148, A1171, A1248, A1460, A1561, A1582, A1936, A2121, A6702, A6743, A6856, A6925, A7013, A7026, A7088, A7148, T0054, T0136, T0141, T0224, T0236, T0237, T0268, T0437, T0592, U0082, U0027, U0093, U0226, U0227
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.