Reported Dec 30, 2020 · Completed
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?
- IceRod" i-Thaw" Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR4070
- UDIs
69 of 69 codes
729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830105729010483010572901048301057290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075729010483007572901048300757290104830075
- Batch Numbers
69 of 69 codes
U1363U0865U0555U0542U0151U0150U0054U0053U0046U0037U0036T0633T0515T0430T0274T0273T0201T0188T0167A7174A7100A7044A7022A7021A6788A6740A2117A2019A1968A1753A1605A1535A1430A1429A1235U1262U1114U1036U0910U0909U0863U0365U0280U0281U0180U0088U0038T0529T0457T0235T0178T0058A6911A6835A6695A6648A2133A2040A2033A1889
- Amount recalled
- 243 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.
Want the full recall guide?
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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