The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Short Term Acute Dialysis Catheters, manufactured by Joline. The affected products were manufactured from Jun 2012 to Feb 2013.
In the course of continuous market surveillance, the manufacturer became aware that occasionally there could be an increased risk of hairline cracks at the connectors of these catheters. It was observed that during the application of the catheter crack formation sporadically occurred. Although there has been no patient endangering so far, blood loss cannot be excluded.
By means of optimized manufacturing processes and improvements of the design, the mechanical and chemical resistance could be enhanced. Until these measures are completely implemented, the manufacturer asks customers to waive alcoholic disinfectants, in no case connect before complete drying as already indicated in the instructions for use and avoid excessive forces when connecting as well as ensure a regular and frequent control of the connectors, and securely clamp affected catheters with the mounted safety clamp and change the catheter. Furthermore, the manufacturer advises distributors to stop selling the affected products.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON286760
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 17 June 2013