FDAFDA · Food and drugs·Recall number Z-1213-2022
FIRMap" Catheter, 60mm Basket
Published June 8, 2022 · Recall initiated: April 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect product labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott
- Distributor
- US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.