Vyaire Medical Recalls Tri-Flo Subglottic Suction System Due to Breakage Risk
Vyaire Medical is recalling the Tri-Flo Subglottic Suction System because the catheter tip may break off and be aspirated by the patient.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Vyaire Medical is recalling the Tri-Flo Subglottic Suction System due to a potential patient safety risk. The distal soft tip of the catheter has been identified as having the potential to break off during patient use. This breakage could result in the aspiration of a solid foreign body.
The recall involves 2,150 units total. The affected products have part number CM28010 and specific lot/serial numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, and 0004008256.
The products were distributed domestically in Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, New Jersey, Ohio, Oklahoma, South Dakota, Texas, Washington, and Wisconsin. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- The Tri-Flo Subglottic Suction System
- Manufacturer
- Vyaire Medical
- Category
- Medical Device — Respiratory
- Affected units
- 2,150
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 (8)
- Part number: CM28010
- Lot/Serial Numbers: 0001158835
- 0001158836
- 0001158837
- 0001185564
- 0001194114
- 0004008255
- 0004008256.
Distribution
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