Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GEM(TM) Recalled by Baxter Healthcare Corp. Due to Instructions for use booklet may puncture the outer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corp. directly.
Affected Products
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-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.
Quantity: 630 units
Why Was This Recalled?
Instructions for use booklet may puncture the outer Tyvek lid.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corp.
Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report