FDA-Device2017-03-15Class II
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient d
Parker Medical
Hazard
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Sold states
Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
Affected count
1,060 units
Manufactured in
5085 Weeping Willow Cir, N/A, Highlands Ranch, CO, United States
Products
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2017Don't want to check this manually?
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