Z-1442-2015 Class II Terminated
FDA device recall Z-1442-2015 was initiated by Baylis Medical Corp * on March 30, 2015 and is designated Class II. Reason for recall: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft. The recall status is terminated (terminated November 17, 2016). Affected quantity: 58 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2015
- Initiation Date
- March 30, 2015
- Termination Date
- November 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 units
Product Description
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.
Reason for Recall
Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
Distribution Pattern
US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR
Code Information
Lots CIFA180814 and CIFA080914