Recall Z-0356-2016— Baylis Medical Corp *

Name: FDA recall Z-0356-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-28

Class II · Terminated

Class II FDA medical device recall by Baylis Medical Corp *, initiated 2015-10-28, terminated 2016-11-17. It names one FDA 510(k) clearance: K014075. Product: 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.. Reason: Microcatheter may have circumferential defects (cracks) along its shaft..

Recalling firm: Baylis Medical Corp *
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Terminated: 2016-11-17
Firm location: Montreal, Canada

510(k) clearances named in this recall

1 on FDA's record

K014075 — BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145Baylis Medical Co., Inc.·cleared 2002-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Microcatheter may have circumferential defects (cracks) along its shaft.

Data sourced from openFDA. This site is unofficial and independent of the FDA.