FDA-Device2022-06-08Class II
FIRMap" Catheter, 60mm Basket
Abbott
Hazard
Incorrect product labeling.
Sold states
US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Affected count
40 units
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
FIRMap" Catheter, 60mm Basket
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief