—#180094

Product

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

FDA product code: MVR — Device, Anastomotic, Microvascular
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K861985
Affected lot / code info: Product Code 511-00200-010; GEM2752; Lots SP19J09-1401617 and SP19J08-1401480

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2020-03-05
Terminated: 2021-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180094. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.