Events

Rappel de Device Recall Introes Pocket Bougie

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Brathwaites Oliver Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75148
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0067-2017
  • Date de mise en oeuvre de l'événement
    2016-08-19
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149464
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Stylet, tracheal tube - Product Code BSR
  • Cause
    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
  • Modèle / numéro de série
    Model OL-E12102, lot# 101615.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Brathwaites Oliver Medical, 96 Terracon Place, Winnipeg Canada Manitoba
  • Source
    USFDA