Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall-Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall-Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized

Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall

Audience: Hospital Risk Managers, Surgical Service personnel
FDA and Gyrus ACMI notified healthcare professionals of a Class I recall of Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm. This device is implanted for ventilation or drainage of the middle ear. Units of the product in lot number MH136952 have been shipped without being sterilized. This product was manufactured only on December 17, 2009 and distributed only on December 22, 2009. Patients should contact their physicians to discuss symptoms that may result from use of the affected products.

Read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204992.htm

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