Summit Medical Recalls Mixed Lot of Armstrong Grommet Ventilation Tubes
Summit Medical, Inc. is recalling one lot of Armstrong Grommet ventilation tubes due to mixed flange types. The agency states this poses no health hazard to users or patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states that the defect 'poses no health hazard to the user or patient,' which aligns with the rubric for cosmetic defects or documentation issues where no adverse health consequences are expected.
Plain-English summary
Summit Medical, Inc. is recalling one lot of Armstrong Grommet with wire Otological Ventilation Tubes (Catalog #: VT-0507-01). The product is intended to provide ventilation to the middle ear space through the tympanic membrane and is sterilized by ethylene oxide. The recall involves 9 boxes of the device, distributed worldwide including the USA (specifically California) and Germany.
The recall was initiated because the lot contained a mix of ventilation tubes with wire attached to slanted flanges and tubes with wire attached to straight flanges. According to the source text, this condition poses no health hazard to the user or patient.
Healthcare providers and patients should stop using the affected lot (Lot #: 147809) and contact Summit Medical, Inc. for further instructions or replacement.
The recalled product
- 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.
- Manufacturer
- Summit Medical, Inc.
- Category
- Medical Device — Otolaryngology
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 147809
Distribution
Distributed in 1 state:
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