Z-1685-2020 Class II Terminated
FDA device recall Z-1685-2020 was initiated by Baxter Healthcare Corporation on March 5, 2020 and is designated Class II. 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 The recall status is terminated (terminated August 2, 2021). Affected quantity: 386 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- March 5, 2020
- Termination Date
- August 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 386 units
Product Description
Reason for Recall
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.