Recall Z-1685-2020 ยท MVR Device, Anastomotic, Microvascular
Baxter Healthcare Corporation
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.
| Date | Mar 5, 2020 |
| Status | Terminated |
| Reason | 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 | Under Investigation by 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. |
| Quantity | 386 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861985 | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) 3M Company, Dec 4, 1986 |