Recall Z-1731-2014 ยท ETD Tube, Tympanostomy
Summit Medical, Inc.
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.
| Date | Jun 9, 2014 (initiated May 12, 2014) |
| Status | Terminated |
| 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. |
| 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 ndove@summitmedicalusa.com. |
| Quantity | 9 boxes |
| Distribution | Worldwide Distribution -- USA, including CA, and GERMANY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS Micromedics, Inc., Mar 7, 1983 |