Z-0668-2021 Class II
FDA device recall Z-0668-2021 was initiated by Boston Scientific Corporation on November 18, 2020 and is designated Class II. Reason for recall: Complaint trend regarding needle shaft gas leaks. Affected quantity: 93 units.
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
- 93 units
Product Description
IceRod" 1.5 90¿ Cryoablation Needle
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3204 UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242 Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903