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.
FDA Recall Z-1685-2020 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeMVR
Date Initiated2020-03-05
Date Terminated2021-08-02
Product Quantity386 units
Reason for Recall
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
Firm Action
An Urgent Product Recall communication was sent 3/5/2020 to affected customers via USPS First Class Mail. The recalling firm is asking that customer locate and remove all affected product from your facility, Contact Synovis MCA to arrange for return and replacement of the product, and complete the Baxter Customer Reply Form and return it to Baxter by fax or email.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - United States Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI and countries of Saudi Arabia, Italy, Austria, Argentina, Japan, Israel, Spain, South Africa, Greece, Australia, France, Sweden, Netherlands, UK, Germany and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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