Brathwaites Oliver Medical recalls The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is u…

Recall date

August 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0067-2017

FDA classification

Class II

Brand / firm

Brathwaites Oliver Medical

Sold / distributed

U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.