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U.S. Department of Health and Human Services

Class 2 Device Recall FIRMap"

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  Class 2 Device Recall FIRMap" see related information
Date Initiated by Firm April 28, 2022
Create Date June 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1213-2022
Recall Event ID 90106
510(K)Number K142182  
Product Classification Catheter, intracardiac mapping, high-density array - Product Code MTD
Product FIRMap" Catheter, 60mm Basket
Code Information 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).
Recalling Firm/
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Shelley Lange
Manufacturer Reason
for Recall
Incorrect product labeling.
FDA Determined
Cause 2
Process control
Action 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.
Quantity in Commerce 40 units
Distribution US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MTD and Original Applicant = TOPERA, INC.