Reported Dec 30, 2020 · Completed
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?
- IcePearl" 2.1 CX Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR3606
- UDIs
7290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041729010483104172901048310417290104831041
- Batch Numbers
U1473U1299U1300U1261U1213U1109U1039U1031U0925U0924U0858U0784U0614U0613U0582U0554U0226U0227U0093U0027U0082T0592T0437T0268T0237T0236T0224T0141T0136T0054A7148A7088A7026A7013A6925A6856A6743A6702A2121A2118A1936A1582A1561A1460A1248A1171
- Amount recalled
- 215 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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