Recalls for Trellis-6 and Trellis-8 peripheral infusion systems

FDA Classifies Previous Covidien Field Action For Its Trellis-6 and Trellis-8 Peripheral Infusion Systems as a Class 1 Recall
02/13/2015 Food Recall

Medtronic announced today that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion systems has now been classified as a Class 1 Recall by the U.S. Food and Drug Administration. Customers were previously notified by Covidien of the recall on December 15, 2014.

  • Company:
    Covidien
  • Problem
    Manufacturing error where the proximal and distal balloon inflation ports were labeled incorrectly, resulting in the potential for incorrect sequence of balloon deflation.