medical Class II Updated 2020-04-15

Baxter Healthcare Corporation recalls GEM Microvascular Anastomotic Coupler Devices - Product Usag

Recalled Product

GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.


Hazard / Issue

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code 5111-00250-060; GEM2753; Lots SP19J11-1402242; SP19J11-1402246; and SP19J11-1402265
View official government recall

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