Baylis Medical Corp * recalls ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used a…

Recall date

March 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1442-2015

FDA classification

Class II

Brand / firm

Baylis Medical Corp *

Sold / distributed

US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR

Why it was recalled

Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.