Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. In
FDA device recall Z-1731-2014 · posted 2014-06-09 · Terminated
Recall details
- Recalling firm
- Summit Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- ETD
- Quantity affected
- 9 boxes
- Distribution
- Worldwide Distribution -- USA, including CA, and GERMANY.
- Date initiated
- 2014-05-12
- Date posted
- 2014-06-09
- Date terminated
- 2014-06-19
- Location
- Eagan, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OTOLOGICAL VENTILATION TUBES-VARIOUS (K830228) | Micromedics, Inc. | 1983-03-07 |