Events

Recall of Device Recall Introes Pocket Bougie

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brathwaites Oliver Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75148
  • Event Risk Class
    Class 2
  • Event Number
    Z-0067-2017
  • Event Initiated Date
    2016-08-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149464
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stylet, tracheal tube - Product Code BSR
  • Reason
    The introes pocket bougie an endotracheal tube introducer size 14 fr (4.7mm) x 60 cm may break during intubation.
  • 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.

Device

Device Recall Introes Pocket Bougie
  • Model / Serial
    Model OL-E12102, lot# 101615.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Brathwaites Oliver Medical

Manufacturer

Brathwaites Oliver Medical
  • Manufacturer Address
    Brathwaites Oliver Medical, 96 Terracon Place, Winnipeg Canada Manitoba
  • Source
    USFDA