Recall Z-1630-2016— Baxter Healthcare Corp.

Name: FDA recall Z-1630-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-21

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2016-04-21, terminated 2016-11-22. It names 2 FDA 510(k) clearances: K143589, K132727. Product: 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.. Reason: Instructions for use booklet may puncture the outer Tyvek lid..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Terminated: 2016-11-22
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K143589 — GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.·cleared 2015-01-16
K132727 — GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Life Technologies, Inc.·cleared 2013-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Instructions for use booklet may puncture the outer Tyvek lid.

Data sourced from openFDA. This site is unofficial and independent of the FDA.