Events

Rappel de Device Recall Breath Tech, Safe Spot Infant Resuscitator

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 Ventlab Corporation.

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
    63347
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0174-2013
  • Date de mise en oeuvre de l'événement
    2012-07-11
  • Date de publication de l'événement
    2012-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113551
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Cause
    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
  • Action
    VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.

Device

Device Recall Breath Tech, Safe Spot Infant Resuscitator
  • Modèle / numéro de série
    Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including IL, OH, NY and TN.
  • Description du dispositif
    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. || The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Adresse du fabricant
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
  • Source
    USFDA