Reported Dec 30, 2020 · Completed
IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
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?
- IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3618
- UDIs
729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089729010483108972901048310897290104831089
- Batch Numbers
U1214U1215U1112U1113U0958U0959U0861U0862U0765U0766U0729U0730U0645U0643U0644U0642U0426U0425U0408U0160U0161T0278T0275T0143T0142T0134T0135A7082A7032A7033A6677A6678A2030A2029A1775A1774A1658A1544A1545A1526A1188A1189
- Amount recalled
- 740 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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