Summary
The FDA issued a Class II for FIRMap" Catheter, 60mm Basket by Abbott. Reason: Incorrect product labeling..
Details
Source
Device Recall
External ID
Z-1213-2022
Action Date
2022-06-08
Status
Terminated
Category
device
Product Description
FIRMap" Catheter, 60mm Basket
Lot/Code Info: 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).
Quantity Affected: 40 units
Reason for Recall
Incorrect product labeling.
Distribution
US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-28
Company
Plymouth, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott has 21 FDA actions in our database, including 15 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott have FDA actions?
Abbott has 21 FDA actions in our database, including 15 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1213-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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