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

Z-1731-2014 Class II Terminated

Recalled by Summit Medical, Inc. — Eagan, MN

Recall Details

Product Type
Devices
Report Date
June 18, 2014
Initiation Date
May 12, 2014
Termination Date
June 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

Other recalls by Summit Medical, Inc.

  • Z-1171-2023 Class II — Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. (January 13, 2023)
  • Z-0435-2016 Class II — AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W (September 3, 2015)
  • Z-1319-2013 Class II — Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit M (March 27, 2013)