Medical Devices
Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches
Recall Class: I
Date Recall Initiated: March 15, 2010
Products:
Surgical Sealant Dispensers
| Model | Lot # & Sterile Lot |
|---|---|
| AMS600-B | 113501 STERILE LOT # 20380 |
| AMS700-B | 113511 STERILE LOT # 20380 |
| ATM100 | 112711 STERILE LOT # 20380 |
| LB-AP-M0001 | 114097 STERILE LOT # 20395 |
| SA-0105 | 114156 STERILE LOT # 20380 |
| SA-3675 | 113532 STERILE LOT # 20380 |
| SA-3678 | 114275 STERILE LOT # 20395 |
Micromedics Nasal Septal Buttons
| Model | Lot # & Sterile Lot |
|---|---|
| SP-78100 | 114149 STERILE LOT # 20395 |
| SP-78105 | 114219 STERILE LOT # 20395 |
Otological Ventilation Tubes
| Model | Lot # & Sterile Lot |
|---|---|
| VT-0101-50 | 114449 STERILE LOT # 20380 |
| VT-0204-01 | 113210 STERILE LOT # 20380 |
| VT-0406-01 | 113228 STERILE LOT # 20395 |
| VT-0503-01 | 113234 STERILE LOT # 20380 |
| VT-0503-01 | 113218 STERILE LOT # 20350 |
| VT-0503-50 | 113236 STERILE LOT # 20380 |
| VT-0508-50 | 113788 STERILE LOT # 20395 |
| VT-0507-01 | 114538 STERILE LOT # 20395 |
| VT 1002-50 | 113248 STERILE LOT # 20380 |
| VT-1035-01 | 114452 STERILE LOT # 20380 |
| VT-1204-01 | 113222 STERILE LOT # 20395 |
| VT-1421-01 | 113431 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.
