• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 64868
Product Type Devices
Status Ongoing
Recalling Firm Covidien LLC
City Mansfield
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X Class II 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 133470 (sets of 2) Z-1184-2013
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X Class II 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 7485 (sets of 2) Z-1185-2013
-
-