FDA Medical Device Recalls (openFDA)
Brathwaites Oliver Medical: 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.
- Recall number
- Z-0067-2017
- Recalling firm
- Brathwaites Oliver Medical
- 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.
- Status
- Terminated
- Initiated
- 2016-08-19
- Posted
- 2016-10-11
- Terminated
- 2019-07-19
- Reason
- The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
- 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 regulatory@bomimed.com to confirm this notification was received.
- Quantity
- 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.
- Lot, serial or model codes
- Model OL-E12102, lot# 101615.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSR
- Firm FEI
- 3003213883
- Firm city
- Winnipeg Canada
- Firm state
- Manitoba
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28