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U.S. Department of Health and Human Services

Class 2 Device Recall FloTrac Sensor

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  Class 2 Device Recall FloTrac Sensor see related information
Date Initiated by Firm July 31, 2013
Date Posted September 11, 2013
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-2189-2013
Recall Event ID 65984
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 CA 92614-5688
For Additional Information Contact
949-250-2500
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		 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 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 = DRS and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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