Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-1630-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-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.

Product Classification:

Class II

Date Initiated: April 21, 2016

Date Posted: May 18, 2016

Recall Number: Z-1630-2016

Event ID: 73908

Reason for Recall:

Instructions for use booklet may puncture the outer Tyvek lid.

Status: Terminated

Product Quantity: 288 units

Code Information:

SPI5El2-1049760 thru SPI5K10-1096019

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated