FDAFDA · Food and drugs·Recall number Z-2676-2020
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Published July 29, 2020 · Recall initiated: June 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The needle surface deteriorated due to unexpected electrolysis during procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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.
- Lot
- UPN: FPRPR3603, GTIN: 7290104831010, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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