Reported Jul 29, 2020 · Terminated
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX…
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, IceFORCE 2.1 CX 90 Needle 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
- UPNFPRPR3602
- GTIN7290104831003
- Batch
723 of 723 codes
A0754A0755A0758A0759A0770A0771A0782A0783A0788A0789A0794A0795A0803A0804A0827A0828A0833A0834A0844A0845A0856A0857A0871A0872A0880A0881A0894A0895A0905A0906A0907A0908A0922A0923A0925A0926A0930A0931A0939A0940A0941A0942A0952A0953A0956A0957A0958A0959A0972A0973A0974A0975A0996A0997A0999A1000A1010A1011A1017A1018
- Amount recalled
- 18440 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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