Recall Z-0067-2017— Brathwaites Oliver Medical

Name: FDA recall Z-0067-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-19

Class II · Terminated

Class II FDA medical device recall by Brathwaites Oliver Medical, initiated 2016-08-19, terminated 2019-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.. Reason: The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation..

Recalling firm: Brathwaites Oliver Medical
Classification: Class II
Status: Terminated
Initiated: 2016-08-19
Terminated: 2019-07-19
Firm location: Winnipeg, Manitoba, Canada

Product description

The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.

Reason for recall

The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.

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