Z-0067-2017Class II

The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer...

Name: Z-0067-2017 The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer...
Creator: Brathwaites Oliver Medical
Published: 2016-08-19
License: https://open.fda.gov/license/

Bomimed Inc / initiated 2016-08-19 / Terminated / root cause: manufacturing process

FDA source

Brathwaites Oliver Medical began a recall of 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... on 2016-08-19. FDA classified it as Class II and gives the reason as "The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0067-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-19
Posted: 2016-10-11
Terminated: 2019-07-19
Recalling firm: Bomimed Inc
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.
Product code: BSR Stylet, Tracheal Tube
Reason for recall: The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included: BOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern. Complete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and applicable shipping instructions to return the affected products. BOMImed Regulatory department also requires the below Customer Confirmation section to be completed and return to [email protected] to confirm this notification was received.
Quantity in commerce: 760 units
Distribution: 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.
Product codes and lots: Model OL-E12102, lot# 101615.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0067-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0067-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-11

Product code BSR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)