Medical device manufacturer, Baylis Medical, has issued a medical device safety alert concerning its ProTrack Microcatheter. The affected part and lot numbers are as follows:
Part number (Lot number): CIC35-145 (CIFA131113, CIFA100614, CIF8100714, C1FA241014)
Part number (Lot number): CIC38-145 (CIFA161013, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA240614, CIFA100714, CIFA180814, CIFA080914, CIFA221014, CIFA050115, CIFA210115 and CIFA060215).
The manufacturer is voluntarily recalling 20 lots of ProTrack Microcatheter (CIC35-145, ClC38-145) due to the possibility that the catheter may have circumferential cracks along its length. The cracks may result in leakage of fluids along the catheter.
According to the manufacturer, there have been no adverse event reports related to this discovery.
Affected users are advised to immediately segregate all affected product and ensure that it will not be used. Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 November 2015