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U.S. Department of Health and Human Services

Class 2 Device Recall FlowCOUPLER

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  Class 2 Device Recall FlowCOUPLER see related information
Date Initiated by Firm July 11, 2014
Date Posted July 29, 2014
Recall Status1 Terminated 3 on May 27, 2015
Recall Number Z-2126-2014
Recall Event ID 68789
510(K)Number K132727  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Code Information Lot Number SPSGT14-02B0027a SPSGT14-04D0005 SPSGT14-04D0023  SPSGT13-10J0016 SPSGT13-11K0041 SPSGT13-12L0008 SPSGT14-01A0009  SPSGT14-02B0026 SPSGT14-04D0015 SPSGT14-04D0026  SPSGT13-10J0017 SPSGT13-11K0039 SPSGT13-11K0042 SPSGT13-12L0015 SPSGT14-01A0028  SPSGT14-02B0028 SPSGT14-02B0033 SPSGT14-04D0014 SPSGT14-04D0027 SPSGT14-05E0005  SPSGT13-10J0018 SPSGT13-11K0040 SPSGT13-12L0007 SPSGT13-12L0012 SPSGT14-01A0027   Part No. 5151-01200-010 5151-01200-010 5151-01200-010   5151-01200-011 5151-01200-011 5151-01200-011 5151-01200-011   5151-01250-010 5151-01250-010 5151-01250-010   5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011   5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010   5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Way
Westlake Village CA 91362-3889
For Additional Information Contact
805-372-3128
Manufacturer Reason
for Recall		 Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
FDA Determined
Cause 2		 Process control
Action Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) sent an Urgent Medical Device Recall letter on July 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the recall is being conducted as a precautionary measure due to the possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored. The recall letter informs the customers of the safety risk and and actions to be taken. Customers with questions about the recall are instructed to contact the Synovis MCA Customer Service unit at (800) 510-3318 or (205) 941-0111.
Quantity in Commerce 1,315 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
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 = DPW and Original Applicant = SYNOVIS LIFE TECHNOLOGIES, INC.
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