IceFORCE" 2.1 CX Prostate Cryoablation Kit recall
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Why was IceFORCE" 2.1 CX Prostate Cryoablation Kit recalled?
Complaint trend regarding needle shaft gas leaks.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN: FPRPR3605 UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034 Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291
- Product
- IceFORCE" 2.1 CX Prostate Cryoablation Kit
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 85 units
- Distribution
- Nationwide
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)