Recall Z-1731-2014— Summit Medical, Inc.

Name: FDA recall Z-1731-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-12

Class II · Terminated

Class II FDA medical device recall by Summit Medical, Inc., initiated 2014-05-12, terminated 2014-06-19. It names one FDA 510(k) clearance: K830228. Product: Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.. Reason: One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient..

Recalling firm: Summit Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Terminated: 2014-06-19
Firm location: Eagan, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K830228 — OTOLOGICAL VENTILATION TUBES-VARIOUSMicromedics, Inc.·cleared 1983-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.

Reason for recall

One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.

Data sourced from openFDA. This site is unofficial and independent of the FDA.