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U.S. Department of Health and Human Services

Safety

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Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall

Audience: Hospital Risk Managers, Surgical Service personnel
[Posted 03/17/2010] 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.
[03/17/2010 - Recall Notice - FDA]