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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and…"
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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