Reported Dec 30, 2020 · Completed
IcePearl" 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?
- IcePearl" 2.1 CX 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3601
- UDIs
436 of 436 codes
729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990729010483099072901048309907290104830990
- Batch Numbers
436 of 436 codes
U1391U1389U1387U1390U1388U1386U1272U1337U1336U1270U1268U1265U1266U1267U1271U1269U1240U1235U1237U1238U1233U1236U1239U1234U1130U1129U1094U1093U1075U1074U1071U1054U0990U0985U0984U0983U0986U0987U0989U0988U0887U0883U0881U0879U0877U0874U0876U0880U0882U0888U0889U0886U0875U0878U0830U0832U0833U0834U0835U0836
- Amount recalled
- 8453 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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