Halyard KimVent Closed Suction System Recalled for Potential Valve Defect
Halyard Health is recalling specific KimVent Turbo-Cleaning Closed Suction Systems for adults because a defective internal valve may allow air to leak from the ventilator circuit.
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 is classified as FDA Class II and involves a medical device defect that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Halyard Health, Inc. is recalling specific lots of the KimVent Turbo-Cleaning Closed Suction System for Adults. The affected products include the 10 F T-Piece (Product Code 227105), 12 F DSE (Product Code 2271603), and 12 F T-Piece (Product Code 227135). The recall involves 11 cases, each containing 20 individual endotracheal tubes, distributed nationwide to locations in California, Massachusetts, Michigan, North Carolina, Texas, Virginia, and Washington.
The recall is due to a potential defect in the internal blue flapper valve. If present, this defect may allow air to leak out of the closed ventilator circuit. The FDA has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected products and contact Halyard Health for further instructions or a replacement.
The recalled product
- Product
- KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
- Manufacturer
- Halyard Health, Inc
- Hazard
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 (4)
- M5019T311
- M4335T317
- M5034T317
- M5040T311 & M5005T303
Distribution
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