Recall Z-1399-2017— Parker Medical

Name: FDA recall Z-1399-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Class II · Terminated

Class II FDA medical device recall by Parker Medical, initiated 2016-12-16, terminated 2017-04-17. It names 2 FDA 510(k) clearances: K092886, K984528. Product: 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. Reason: 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..

Recalling firm: Parker Medical
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Terminated: 2017-04-17
Firm location: Highlands Ranch, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K092886 — WELL LEAD ENDOBRONCHIAL TUBESWell Lead Instruments·cleared 2010-03-11
K984528 — PARKER FLEX-TIP TRACHEAL TUBEParker Medical Assoc.·cleared 1999-07-15

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 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

Reason for recall

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.

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