Z-0356-2016 Class II Terminated
FDA device recall Z-0356-2016 was initiated by Baylis Medical Corp * on October 28, 2015 and is designated Class II. Reason for recall: Microcatheter may have circumferential defects (cracks) along its shaft. The recall status is terminated (terminated November 17, 2016). Affected quantity: 433 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- October 28, 2015
- Termination Date
- November 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 433 units
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.
Distribution Pattern
Nationwide Distribution.
Code Information
CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215