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.
FDA Recall Z-1731-2014 · Posted 2014-06-09
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Recalling FirmSummit Medical, Inc.
Recall StatusTerminated
Product CodeETD
Date Initiated2014-05-12
Date Terminated2014-06-19
Product Quantity9 boxes
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.
Firm 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].
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- USA, including CA, and GERMANY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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