Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm

Recall Class: Class I

Date Recall Initiated: January 8, 2010

Product:

Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm

Catalog (REF) Number 145281-ENT, Lot Number MH136952

This product was manufactured only on December 17, 2009 and distributed only on December 22, 2009.

Use:

This product is intended to be implanted for ventilation or drainage of the middle ear.

Recalling Firm:

Gyrus ACMI, Incorporated
136 Turnpike Road
Southborough, Massachusetts 01772-2118

Reason for Recall:

Units of the product in lot number MH136952 have been shipped without being sterilized.

Public Contact:

The company may be contacted at 1-800-773-4301.

FDA District: New Orleans

FDA Comments:

On January 4, 2010, the firm called or visited their customers to inform them about a recall of the firm’s product. 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.

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.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.