FIRMap" Catheter, 60mm Basket
Hazard
Incorrect product labeling.
What You Should Do
The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: EPCcompliance@abbott.com, and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.
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Products
- Brand
- Abbott
- UPC
- 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).
Units Affected
40 units