A Class I recall has been issued for the Tri-Flo Subglottic Suction System from Vyaire Medical. Use of these devices may cause serious injuries or death, the FDA reports.
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According to the FDA, there is a risk that the distal soft tip of the catheter may break off and enter the patient’s lungs, which may result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient’s lungs, irritation and reddening of the skin (erythema) of the airways, infections or death.
- Lot numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256
- Model Number: CM28010
- Manufacturing Dates: Unknown
- Distribution Dates: January 23, 2018 to May 23, 2018
- Devices Recalled in the U.S.: 2,150 units nationwide
More information is available on the FDA’s website.