The recalled device is intended to be implanted for ventilation or drainage of the middle ear. A Class I recall has been issued by Gyrus ACMI, Inc. for Micron Bobbin Vent Tube T, 1.27 mm. The recalled device is intended to be implanted for ventilation or drainage of the middle ear.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
This recall applies to devices bearing Catalog (REF) Number 145281-ENT
This recall applies to devices bearing Catalog (REF) Number 145281-ENT, Lot Number MH136952. The affected products were manufactured only on December 17, 2009 and distributed only on December 22, 2009.
According to the recall notice, the recall has been issued because devices with the affected Lot Number may not have been sterilized.
On January 4, 2010, Gyrus ACMI called or visited their customers to inform them about a recall of this device. On January 27, 2010, the firm sent a follow-up letter to their customers and implanting surgeons with a description of the issue and instructions for the return of the affected product.
Patients should contact their physicians to discuss symptoms that may result from use of the affected products.
Gyrus ACMI may be contacted at 1-800-773-4301.