Covidien issues a recall on a lot of its Roticulator single-use staplers over concerns about contamination.
Covidien's Hong Kong division this week launched a recall of a lots of its Roticulator single-use staplers over concerns that the sterility barrier on the devices may be compromised.
Covidien warned that use of the products may increase a patient's risk of infection and asked that health providers identify and quarantine all affected inventory for return to the company.
"This voluntary recall is being conducted with the knowledge of the FDA," according to the recall letter.
The recall includes 2 models of the Roticulator 55 and 3 models of the Roticulator 30 single-use staplers. The device giant added that the Roticulator staples may have been incorporated into Best Practice Kits.
The devices are used to place double or triple staggered rows of staples in abdominal, gynecological, pediatric and thoracic surgeries.
Covidien did not immediately respond to requests for comment. The company has yet to make any announcements about further actions.
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