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Class I Medical Device Recall: Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological

Posted Nov 23 2010 12:00am

Recall Class: I

Date Recall Initiated: March 15, 2010

Products:

Surgical Sealant Dispensers

ModelLot # & Sterile Lot
AMS600-B113501 STERILE LOT # 20380
AMS700-B113511 STERILE LOT # 20380
ATM100112711 STERILE LOT # 20380
LB-AP-M0001114097 STERILE LOT # 20395
SA-0105114156 STERILE LOT # 20380
SA-3675113532 STERILE LOT # 20380
SA-3678114275 STERILE LOT # 20395

Micromedics Nasal Septal Buttons
ModelLot # & Sterile Lot
SP-78100114149 STERILE LOT # 20395
SP-78105114219 STERILE LOT # 20395

Otological Ventilation Tubes
ModelLot # & Sterile Lot
VT-0101-50114449 STERILE LOT # 20380
VT-0204-01113210 STERILE LOT # 20380
VT-0406-01113228 STERILE LOT # 20395
VT-0503-01113234 STERILE LOT # 20380
VT-0503-01113218 STERILE LOT # 20350
VT-0503-50113236 STERILE LOT # 20380
VT-0508-50113788 STERILE LOT # 20395
VT-0507-01114538 STERILE LOT # 20395
VT 1002-50113248 STERILE LOT # 20380
VT-1035-01114452 STERILE LOT # 20380
VT-1204-01113222 STERILE LOT # 20395
VT-1421-01113431 STERILE LOT # 20395

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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