Reported Dec 30, 2020 · Completed
IceSeed" 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?
- IceSeed" Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR4518
- UDIs
7290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075
- Batch Numbers
U1262U1114U1036U0910U0909U0863U0365U0280U0281U0180U0088U0038T0529T0457T0235T0178T0058A6911A6835A6695A6648A2133A2040A2033A1889A1634A1368A1225
- Amount recalled
- 211 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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