Initially noted in a release issued by the company’s Hong Kong division, 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.
The issue was discovered during an internal audit of the company’s products, a Covidien spokesman told MassDevice.com today. The company is working with the FDA to take the next steps in recalling the affected Roticulator lots.
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.
The company does not plan to issue a press release on the recall as the incident is "not material," according to the spokesman.
COV shares were down 2.1% to $52.56 as of about 3:00 p.m. today.