Reported Jul 29, 2020 · Terminated
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Lot codes and dates
- UPNFPRPR3601
- GTIN07290104830990
- Batch numbers
311 of 311 codes
A0735A0736A0749A0750A0798A0799A0817A0818A0840A0841A0874A0875A0888A0889A0898A0899A0945A0946A0950A0951A0992A0993A1003A1004A1005A1006A1012A1027A1028A1078A1079A1090A1091A1096A1097A1098A1099A1111A1112A1143A1144A1155A1156A1168A1169A1190A1191A1192A1204A1205A1223A1224A1232A1233A1268A1271A1272A1296A1297A1299
- Amount recalled
- 7536 devices
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
The needle surface deteriorated due to unexpected electrolysis during procedure.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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