FDA Recall
Terminated
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.
Recall: Z-0356-2016
·
Initiated October 28, 2015
Recall
- Recall Number
- Z-0356-2016
- Event Number
- 72539
- Firm
- Baylis Medical Corp 5959 TransCanada Highway Montreal Canada
- FEI Number
- 3005241199
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 28, 2015
- Posted
- December 1, 2015
- Terminated
- November 17, 2016
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
Microcatheter may have circumferential defects (cracks) along its shaft.
Action
Recall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm.
Distribution
Nationwide Distribution.
Quantity
433 units