Medical device manufacturer, Covidien, is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units (SULU). In addition, the Company has discontinued manufacturing the Duet TRS™ Universal Straight and Articulating SULU. Serious injuries and/or deaths could occur due to the failure mode associated with this recall.
Covidien has received one report that links the Duet TRS™ tissue reinforcement material to a postoperative injury after abdominal surgery. The Company has concluded that Duet TRS™ may have the potential to injure adjacent anatomical structures, which may result in life threatening postoperative complications. Specifically, exposed edges of tissue reinforcement material may cause lacerations, punctures or trauma to adjacent anatomical structures resulting in pain, bleeding or other post-operative complications.
This is in addition to the recall conducted in January of 2012 which contra-indicated the use of Duet TRS™ for thoracic surgery. At that time, Covidien received reports of thirteen serious injuries and three deaths, following the application of Duet TRS™ in the thoracic cavity.
According to the local supplier, the affected product has been distributed in Hong Kong.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 24 August 2012