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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode

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 Class 2 Device Recall Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrodesee related information
Date Initiated by FirmApril 08, 2013
Date PostedApril 29, 2013
Recall Status1 Terminated 3 on November 19, 2015
Recall NumberZ-1185-2013
Recall Event ID 64868
510(K)NumberK012218 
Product Classification Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
ProductMedi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Code Information Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
Recalling Firm/
Manufacturer		 Covidien LLC
15 Hampshire Street
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer Reason
for Recall		Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
FDA Determined
Cause 2		Process control
ActionCovidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500.
Quantity in Commerce7485 (sets of 2)
DistributionWorldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
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 = DRO
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