The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Arrow Edge Hemodialysis Catherization Set Long-Term Access, and Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access Hemodialysis Catheters, manufactured by Arrow International, Inc.
The manufacturer has issued a voluntary recall for some lots of the hemodialysis catheter product codes due to receipt of complaints that the tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. The manufacturer advises users to cease use and distribution of stock of affected product and quarantine immediately.
According to the local supplier, Cemma Enterprise, the devices were not distributed in Hong Kong.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON371783
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 11 February 2014