Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Devi…

Recall date

April 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1631-2016

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

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

Why it was recalled

Instructions for use booklet may puncture the outer Tyvek lid.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.