Device product
FIRMap" Catheter, 60mm Basket
Z-1213-2022
Product summary
- Firm
- Abbott
- Event
- Event 90106
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1213-2022
Official wording
Reason: Incorrect product labeling.
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).
Distribution pattern: US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Derived failure modes
-
Labeling or packaging
Incorrect product labeling