Z-1685-2020Class II

GEM Microvascular Anastomotic Coupler Devices -

Name: Z-1685-2020 GEM Microvascular Anastomotic Coupler Devices -
Creator: Baxter Healthcare Corporation
Published: 2020-03-05
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-03-05 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in... on 2020-03-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1685-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-05
Posted: 2020-04-08
Terminated: 2021-08-02
Recalling firm: Baxter Healthcare Corporation
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.
Product code: MVR Device, Anastomotic, Microvascular
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
Root cause tag: labeling and UDI
FDA 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 in commerce: 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, Spain, South Africa, Greece, Australia, France, Sweden, Netherlands, UK, Germany and Canada.
Product codes and lots: Product Code 5111-00250-060; GEM2753; Lots SP19J11-1402242; SP19J11-1402246; and SP19J11-1402265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-08
Z-1686-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-08
Z-1687-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-08

Product code MVR

K861985Class II3M Brand Microvascular Anastomotic Coupler (27Xx)3M Company / cleared 1986-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)