VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Steril

FDA device recall Z-0348-2011 · posted 2010-11-18 · Terminated

Recall details

Recalling firm

Micromedics, Inc.

Reason for recall

Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.

Action taken

Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.

Root cause

Packaging process control

Status

Terminated

Product code

ETD

Quantity affected

VT 213 (1982 pouches); ET 50 (500 pouches)

Distribution

Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IREL

Date initiated

2010-03-15

Date posted

2010-11-18

Date terminated

2011-06-21

Location

Eagan, MN