FDA-Device2016-07-27Class II

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

Parker Medical
Hazard

Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

Sold states
US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
Affected count
5,500 units
Manufactured in
5085 Weeping Willow Cir, N/A, Highlands Ranch, CO, United States
Products
Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2016

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