FIRMap" Catheter recall: Labeling Error
FIRMap" Catheter, 60mm Basket
Why was FIRMap" Catheter recalled?
Incorrect product labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- FIRMap" Catheter, 60mm Basket
- Recalling firm
- Abbott
- Quantity
- 40 units
- Distribution
- US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)