Covidien conducts voluntary recall and discontinues Duet TRS reload

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Covidien has announced that it 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. 

Covidien has received one report that links the Duet TRS tissue reinforcement material to a post-operative 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 post-operative complications. This voluntary recall is in addition to the recall announced 16 January 2012, relating to the contraindication of the device in the thoracic cavity. At that time, Covidien received reports of 13 serious injuries and 3 fatalities following the application of Duet TRS in the thoracic cavity.

The affected product codes and descriptions are as follows:

DUET4535

 

 

 

 

 

 

Duet TRS 45 3.5MM STRAIGHT SULU

DUET4535A

           

Duet TRS 45 3.5MM ARTICULATING SULU

DUET4548

           

Duet TRS 45 4.8MM STRAIGHT SULU

DUET4548A

           

Duet TRS 45 4.8MM ARTICULATING SULU

DUET6035

           

Duet TRS 60 3.5MM STRAIGHT SULU

DUET6035A

           

Duet TRS 60 3.5MM ARTICULATING SULU

DUET6048

           

Duet TRS 60 4.8MM STRAIGHT SULU

DUET6048A

           

Duet TRS 60 4.8MM ARTICULATING SULU


Launched in 2009, the Duet TRS reload is a SULU with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the company has sold more than 540,000 units worldwide.


Customers have been notified of this recall by letter on 21 August 2012. All Duet TRS product can be returned by contacting Customer Service at feedback.customerservice@covidien.com or +1 800 722 8772, option 1, to obtain a Return Goods Authorisation (RGA) prior to returning the affected units.


Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting programme either online, by fax or by phone.

 

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