Reported Dec 9, 2015 · Terminated
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a…
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
Is this the product you have?
- 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.
- Lot codes and dates
CIFA161013CIFA131113CIFA271113CIFA311213CIFA210214CIFA070314CIFA270314CIFA070514CIFA210514CIFA100614CIFA240614CIFB100714CIFA100714CIFA180814CIFA080914CIFA241014CIFA221014CIFA050115CIFA210115CIFA060215
- Amount recalled
- 433 units
Where it was sold
- Nationwide
Why it was recalled
Microcatheter may have circumferential defects (cracks) along its shaft.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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