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U.S. Department of Health and Human Services

Class 2 Device Recall GEM2754FC (3.0mm)

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  Class 2 Device Recall GEM2754FC (3.0mm) see related information
Date Initiated by Firm April 21, 2016
Create Date May 10, 2016
Recall Status1 Terminated 3 on November 22, 2016
Recall Number Z-1629-2016
Recall Event ID 73908
510(K)Number K132727  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC

Product Usage:
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Code Information SP15H05-1067841 thru SP15L02-1102423
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Instructions for use booklet may puncture the outer Tyvek lid.
FDA Determined
Cause 2		 Package design/selection
Action Baxter sent an Urgent Product Recall letter dated April 21, 2016 to customer. The letter identified the affected product, problem and actions to be taken. The letters requested that direct consignees contact Synovis MCA to arrange for return and credit. Companies that further distributed the product were asked to notify other facilities or departments. For questions contact Synovis MCA at 800-510-3318 or 205-941-0111.
Quantity in Commerce 707 units
Distribution Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
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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