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.
Reported: April 15, 2020 Initiated: March 5, 2020 #Z-1686-2020
Product Description
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.
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
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 209 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1686-2020.
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