Reported Dec 30, 2020 · Completed
Five IceRod" i-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?
- Five IceRod" i-Thaw" Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR3571
- UDIs
72901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976729010483097672901048309767290104830976
- Batch Numbers
U1264U1226U1089U1012U1009U0827U0772U0767U0491T0817T0693T0725T0587T0487T0486T0313A7114A6823A2113A1942A1712A1257A1252
- Amount recalled
- 178 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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