Reported Dec 30, 2020 · Completed
IceRod" He-Thaw Prostate Cryoablation Kit
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 · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- IceRod" He-Thaw Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR4570
- UDIs
729010483009972901048300997290104830099729010483009972901048300997290104830105729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099729010483009972901048300997290104830099
- Batch Numbers
G5063G5871G5900G5902G5975P1901P2150P2204P2206P2207P2240P2241P2242P2243P2245P2247P2249P2251P2253P2254P2256P2258P2259P2261P2262P2263P2268P2272P2274P2404P2405P2406P2411
- Amount recalled
- 115 units
This recall covers 37 products
The agency filed one notice per product. You are reading one of them; the other 36 are below.
24 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Complaint trend regarding needle shaft gas leaks.
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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