Recall Z-2243-2016— Parker Medical

Name: FDA recall Z-2243-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-02

Class II · Terminated

Class II FDA medical device recall by Parker Medical, initiated 2016-06-02, terminated 2017-01-31. It names one FDA 510(k) clearance: K110269. Product: 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.. Reason: 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..

Recalling firm: Parker Medical
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Terminated: 2017-01-31
Firm location: Highlands Ranch, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K110269 — WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALWell Lead Medical Co., Ltd.·cleared 2011-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.