Device 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.
Z-0067-2017
Product summary
- Event
- Event 75148
- Status
- Terminated
- Classification
- Class II
- Quantity
- 760 units
- Official record key
device-enforcement:Z-0067-2017
Official wording
Reason: The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Code information: Model OL-E12102, lot# 101615.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.