Reported Dec 30, 2020 · Completed
IceFORCE" 2.1 CX 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 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3602
- UDIs
1,049 of 1,049 codes
729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003729010483100372901048310037290104831003
- Batch Numbers
1,049 of 1,049 codes
U1397U1395U1359U1357U1396U1394U1355U1353U1351U1349U1347U1338U1340U1342U1344U1346U1348U1354U1352U1358U1356U1350U1345U1341U1343U1339U1298U1296U1294U1292U1290U1288U1286U1284U1282U1280U1278U1276U1274U1273U1279U1283U1285U1287U1291U1293U1277U1297U1281U1275U1289U1295U1260U1258U1256U1254U1252U1204U1246U1247
- Amount recalled
- 22,289 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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