Home / Recalls / Summit Medical, Inc. / Z-1731-2014

Z-1731-2014 Class II Terminated

Recalled by Summit Medical, Inc. — Eagan, MN

FDA device recall Z-1731-2014 was initiated by Summit Medical, Inc. on May 12, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jun 19, 2014). Affected quantity: 9 boxes.

Recall details

Product Type: Devices
Report Date: Jun 18, 2014
Initiation Date: May 12, 2014
Termination Date: Jun 19, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 boxes

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.

Distribution pattern

Worldwide Distribution -- USA, including CA, and GERMANY.

Code information

Lot #: 147809

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1731-2014
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.