Baylis Medical Corp * recalls ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a…
- Recall date
- October 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0356-2016
- FDA classification
- Class II
- Brand / firm
- Baylis Medical Corp *
- Sold / distributed
- Nationwide Distribution.
Why it was recalled
Microcatheter may have circumferential defects (cracks) 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. 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.
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