Reported Apr 22, 2015 · Terminated

ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used…

Baylis Medical Corp. *

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baylis Medical Corp * · 5959 TransCanada Highway · Montreal, N/A · N/A

Is this the product you have?

  • ProTrack Microcatheter
  • Product UsageThe 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
Lot codes and dates
  • Lots CIFA180814 and CIFA080914
Amount recalled
58 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 17, 2016 · Data as of Sep 19, 5:38 PM UTC

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