Recall Z-1213-2022
Abbott · initiated April 28, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
FIRMap" Catheter, 60mm Basket
Codes / lots: 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).
Reason for recall
Incorrect product labeling.
FDA-determined cause: Process control
Action taken
The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: EPCcompliance@abbott.com, and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.
Details
- Recall number
- Z-1213-2022
- Initiated
- April 28, 2022
- Terminated
- June 18, 2024
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Quantity
- 40 units
- Distribution
- US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
- Recalling firm
- Abbott, Plymouth, MN