Z-0662-2021 Class II
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 18, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261 units
Product Description
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3617 UDIs: 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072 Batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177