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U.S. Department of Health and Human Services

Class 2 Device Recall FloTrac Sensor

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 Class 2 Recall
FloTrac Sensor
see related information
Date Posted September 11, 2013
Recall Status1 Open
Recall Number Z-2189-2013
Recall Event ID 65984
Premarket Notification
510(K) Number
K043065 
Product Classification Transducer, Blood-Pressure, Extravascular - Product Code DRS
Product "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Code Information 595531157
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine, California 92614-5688
Manufacturer Reason
for Recall
The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were instruct4ed to call Edwards Customers Service at 1-800-424-3278. For questions regarding this recall call 972-410-7100.
Quantity in Commerce 35 units
Distribution Nationwide Distribution including MO and MI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DRS and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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