FDA-Device2021-02-10Class II
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Baxter Healthcare Corporation
Hazard
Potential for the battery to lose its ability to be recharged.
Sold states
Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD
Affected count
109 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2021Don't want to check this manually?
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