Z-1731-2014Class II

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide...

Name: Z-1731-2014 Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide...
Creator: Summit Medical, Inc.
Published: 2014-05-12
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2014-05-12 / Terminated / root cause: manufacturing process

FDA source

Summit Medical, Inc. began a recall of Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the... on 2014-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1731-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Posted: 2014-06-09
Terminated: 2014-06-19
Recalling firm: Summit Medical, LLC
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.
Product code: ETD Tube, Tympanostomy
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees was sent a Summit Medical "Medical Device Recall" letter, dated May 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to examine their inventory and to quarantine the product. Consignees need to immediately examine their inventory quarantine any affected product. Also, they are to complete and return the "Recall Response Form." For questions they can contact Nicole Dove at (651) 789-3921 or [email protected].
Quantity in commerce: 9 boxes
Distribution: Worldwide Distribution -- USA, including CA, and GERMANY.
Product codes and lots: Lot #: 147809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1731-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1731-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code ETD

K830228Class IIOtological Ventilation Tubes-VariousMicromedics, Inc. / cleared 1983-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)