Z-1213-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- April 28, 2022
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
FIRMap" Catheter, 60mm Basket
Reason for Recall
Incorrect product labeling.
Distribution Pattern
US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Code Information
Model Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).