FDAFDA · Food and drugs·Recall number Z-0067-2017
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.
Published October 19, 2016 · Recall initiated: August 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brathwaites Oliver Medical
- Distributor
- 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.
- Lot
- Model OL-E12102, lot# 101615.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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