Home / Recalls / Baxter Healthcare Corp. / Z-1631-2016

Z-1631-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
May 18, 2016
Initiation Date
April 21, 2016
Termination Date
November 22, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
118 units

Product Description

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.

Reason for Recall

Instructions for use booklet may puncture the outer Tyvek lid.

Distribution Pattern

Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada

Code Information

SPI5E12-1049765 thru SPl5Hl8-1071450

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