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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 FirmApril 28, 2022
Create DateJune 01, 2022
Recall Status1 Terminated 3 on June 18, 2024
Recall NumberZ-1213-2022
Recall Event ID 90106
510(K)NumberK142182 
Product Classification Catheter, intracardiac mapping, high-density array - Product Code MTD
ProductFIRMap" 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/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information ContactShelley Lange
651-756-4091
Manufacturer Reason
for Recall		Incorrect product labeling.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce40 units
DistributionUS Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MTD
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