FDA Device recall Z-0067-2017
The Introes Pocket Bougie is an endotracheal tube introducer
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of The Introes Pocket Bougie is an endotracheal tube introducer by Brathwaites Oliver Medical, citing the Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0067-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-19 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Brathwaites Oliver Medical |
| Distribution | AZ, CT, IL, IN, MA, MO, NC, NE, NY, OH, OR, PA, UT, WI |
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.
Identifiers
| code_info | Model OL-E12102, lot# 101615. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2017%22
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