Z-0067-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- August 19, 2016
- Termination Date
- July 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 760 units
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.
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.
Code Information
Model OL-E12102, lot# 101615.