CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
The Introes Pocket Bougie is an endotracheal tube introducer recalled
Brathwaites Oliver Medical is recalling The Introes Pocket Bougie is an endotracheal tube introducer, distributed in 14 states. The recall was initiated on 19 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0067-2017
- FDA event ID
- 75148
- Recalling firm
- Brathwaites Oliver Medical, Winnipeg, Manitoba
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2016
- FDA classified
- 11 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 19 Aug 2016 | Recall initiated by company | |
| 11 Oct 2016 | Classified by FDA | +53 days |
| 19 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was 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.
ArizonaConnecticutIllinoisIndianaMassachusettsMissouriNorth CarolinaNebraskaNew YorkOhioOregonPennsylvaniaUtahWisconsin
Questions about this recall
Why was it recalled?
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Which lots are affected?
Model OL-E12102, lot# 101615.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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