| Subject: | Class I Recall of Gyrus ACMI Micron Bobbin Vent Tube T |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 17 Mar 2010 - 05:00 pm |
| Audience: Hospital Risk Managers, Surgical Service personnel The Food and Drug Administration (FDA) and Gyrus ACMI have 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... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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