Recall Z-1213-2022— Abbott

Name: FDA recall Z-1213-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-28

Class II · Terminated

Class II FDA medical device recall by Abbott, initiated 2022-04-28, terminated 2024-06-18. It names one FDA 510(k) clearance: K142182. Product: FIRMap" Catheter, 60mm Basket. Reason: Incorrect product labeling..

Recalling firm: Abbott
Classification: Class II
Status: Terminated
Initiated: 2022-04-28
Terminated: 2024-06-18
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K142182 — FRIMAP ADAPTER CONNECTOR (MAC)Topera, Inc.·cleared 2014-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FIRMap" Catheter, 60mm Basket

Reason for recall

Incorrect product labeling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.