PlainRecalls
FDA Devices Moderate Class II Terminated

FIRMap" Catheter, 60mm Basket

Reported: June 8, 2022 Initiated: April 28, 2022 #Z-1213-2022

Product Description

FIRMap" Catheter, 60mm Basket

Reason for Recall

Incorrect product labeling.

Details

Recalling Firm
Abbott
Units Affected
40 units
Distribution
US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Location
Plymouth, MN

Frequently Asked Questions

What product was recalled?
FIRMap" Catheter, 60mm Basket. Recalled by Abbott. Units affected: 40 units.
Why was this product recalled?
Incorrect product labeling.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1213-2022.