Class I Medical Device Recall: Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes ? Sealed in Pouches

By Effective Medicine  On  In Medical Devices Tagged  


Recall Class: I

Date Recall Initiated: March 15, 2010

Products:

Surgical Sealant Dispensers

 

Micromedics Nasal Septal Buttons

Otological Ventilation Tubes

These products were manufactured from February 9, 2010 through March 4, 2010 and distributed from February 15, 2010 through March 4, 2010.

Use:

  • Surgical Sealant Dispenser – Instrument for the application of two liquids
  • Micromedics Nasal Septal Button – Used for nonsurgical closure of an opening in the septum of the nose
  • Otological Ventilation Tubes – Implants designed to provide ventilation to the middle ear space through the eardrum (tympanic membrane). Used when there is a chronic failure of the tube that connects the middle ear to the nose (Eustachian tube) and when the problem does not respond to conventional therapy.

Recalling Firm:

Micromedics, Inc.
1270 Eagan Industrial Road, Suite 120
Eagan, Minnesota 55121-1385

Reason for Recall:

These medical products are contained in sterile pouches that have weak or open seals. These products could become or have been contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death.

Public Contact:

Customers can contact the company at 1-800-624-5662 or 651-452-1977 ext. 224., Monday- Friday, 7:30am-5pm, Central Time.

FDA District: Minneapolis

FDA Comments:

On March 15, 2010, the company sent its customers a Product Recall letter describing the products being recalled, the product sterility issue, and actions to be taken.

Micromedics advised its customers to contact their Customer Service to return any affected product for replacement. Customers can contact Micromedics at one of the phone numbers listed above.

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.

    





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