FDA-Device2017-09-13Class II
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Microvention, Inc.
Hazard
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Sold states
Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
Affected count
34 units
Manufactured in
1311 Valencia Ave, N/A, Tustin, CA, United States
Products
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3103-2017Don't want to check this manually?
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