Covidien Plc (COV) said it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single-Use Loading Units, or SULU. Besides, the company has discontinued manufacturing the Duet TRS Universal Straight and Articulating SULU.
The company stated that it obtained one report that links the Duet TRS tissue reinforcement material to a post-operative injury after abdominal surgery. Covidien concluded that Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications.
The affected product codes are DUET4535, DUET4535A, DUET4548, DUET4548A, DUET6035, DUET6035A, DUET6048 and DUET6048A.
The above-mentioned voluntary recall is in addition to the recall announced January 16, 2012, relating to the contraindication of the device in the thoracic cavity.
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