Abbott: Medical Device Recall in 2022 - (Recall #: Z-1213-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

FIRMap" Catheter, 60mm Basket

Product Classification:

Class II

Date Initiated: April 28, 2022
Date Posted: June 8, 2022
Recall Number: Z-1213-2022
Event ID: 90106
Reason for Recall:

Incorrect product labeling.

Status: Terminated
Product Quantity: 40 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated