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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm August 19, 2015
Date Posted September 02, 2015
Recall Status1 Terminated 3 on May 24, 2017
Recall Number Z-2546-2015
Recall Event ID 71963
510(K)Number K012218  
Product Classification Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
Product MediTrace Cadence Adult Zoll, Preconnect
Defibrillation Electrode, Nonsterile

Item Code:22770PC
Code Information Lot Numbers: 516313X, 519124X, 513426X
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
FDA Determined
Cause 2		 Process control
Action Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878.
Quantity in Commerce 114,000 sets
Distribution Nationwide Foreign: Canada Australia Denmark Germany New Zealand
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRO and Original Applicant = THE LUDLOW COMPANY LP
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