Class 2 Device Recall GEM2756FC (4.0mm)

• Date Initiated by Firm: April 21, 2016
• Create Date: May 10, 2016
• Recall Status: Terminated on November 22, 2016
• Recall Number: Z-1631-2016
• Recall Event ID: 73908
• 510(K)Number: K143589
• Product Classification: Flowmeter, blood, cardiovascular - Product Code DPW
• Product: GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-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: SPI5E12-1049765 thru SPl5Hl8-1071450
• 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: 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: 118 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