Reported Dec 30, 2020 · Completed
Three IcePearl" 2.1 CX 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?
- Three IcePearl" 2.1 CX Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR3608
- UDIs
7290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065729010483106572901048310657290104831065
- Batch Numbers
U1308U1304U1066U1034U0859U0860U0661U0660U0609U0588T0815T0816T0270T0238T0212T0211T0181T0144T0055A7122A7027A7014A6926A6913A6900A6857A6744A6710A1937A1583A1461
- Amount recalled
- 117 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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