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

Enforcement Report - Week of August 22, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 62278
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Irvine
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring. 59267057 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2198-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring. 59163071, 59174300, 59178366, 59233787 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2197-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring. 59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2196-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring. 59174297, 59194298, 59194299, 59197887, 59203360, 59203361, 59207070, 59219837, 59247401, 59247402 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2195-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring. 59194334, 59224788, 59239507, 59247472 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2194-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring. 59194300, 59203362, 59216087, 59233785, 59243242 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2193-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring. 59197000, 59197001, 59216091, 59218827, 59238961 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2192-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring. 59169527, 59169528, 59174318, 59174320, 59194314, 59194315, 59194316, 59194317, 59197004, 59197005, 59197006, 59197007, 59197008, 59197009, 59197010, 59197897, 59197898, 59197899, 59197900, 59197901, 59197902, 59197903, 59203374. 59203375, 59203377, 59203378, 59203379, 59203380, 59203381, 59207074, 59207075, 59207076, 59207077, 59216092, 59216093, 59216094, 59216096, 59216097, 59216098, 59216099, 59219846, 59230687, 59230688, 59230689, 59230690, 59230691, 59230692, 59233882, 59238962, 59238963, 59238964, 59238965, 59243250, 59243249, 59247419, 59247421, 59247420, 59247422, 59247423, 59247424, 59247425, 59247426, 59247427, 59247428, 59247429 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2191-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring. 59174383, 59174384, 59216111, 59219855, 59233891, 59247471, 59252542 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2190-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring. 59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2189-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. 59243259, 59263146 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. 32,145 units for all products in Recall Event Z-2188-2012
-
-