FDA-Device2015-12-09Class II
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Baylis Medical Corp *
Hazard
Microcatheter may have circumferential defects (cracks) along its shaft.
Sold states
Nationwide Distribution.
Affected count
433 units
Manufactured in
5959 TransCanada Highway, Montreal, Canada
Products
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0356-2016Don't want to check this manually?
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