The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device alert concerning Trak Back Pullback Device, manufactured by Volcano Corporation, with the following details:
There is a concern related to the integrity of the primary pouch packaging that may impact the product sterility after shipment. Should the integrity of the primary pouch packaging fail to maintain sterility of the device, the use of this device could potentially lead to the introduction of contamination into the sterile field, which could potentially lead to an adverse reaction to the patient.
The manufacturer asks users to immediately cease use of the Trak Back II device and return unused devices to distribution centre.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON448384
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 2 Sep 2014