Recall Z-1686-2020
Baxter Healthcare Corporation · initiated March 5, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Codes / lots: Product Code 5111-00200-060; GEM2752; Lots SP19J08-1401476 and SP19J09-1401614
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
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1686-2020
- Initiated
- March 5, 2020
- Terminated
- August 2, 2021
- Product code
- MVR – Device, Anastomotic, Microvascular
- Quantity
- 209 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1685-2020 Class II | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in…The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the… | 03/05/2020Terminated |
| Z-1687-2020 Class II | GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis…The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the… | 03/05/2020Terminated |