Events

Rappel de Bio Med Devices

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 Biomed Devices.

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
    57051
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0972-2011
  • Date de mise en oeuvre de l'événement
    2010-10-19
  • Date de publication de l'événement
    2011-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95250
  • 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, continuous, facility use - Product Code CBK
  • Cause
    Breathing circuit may disconnect between the adapter adjacent tubing cuff.
  • Action
    The firm,Bio Med Devices, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 18, 2010 via fax to the customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to immediately examine their stock for the affected lots, if found, discontinue distributing and using the product and promptly return via UPS #025106 to Bio-Med Devices 61 Soundview Rd, Guilford, CT 06437, Attention: 4040LC Recall Return. The customers were also instructed to immediately contact their accounts, if the product was further distributed , advise them of the recall situation and have their outstanding product returned, and to complete and return the RETURN FAX-IMMEDIATE RESPONSE REQUIRED form via fax to 203-458-0440. Note: Bio-Med informed the customers that they will credit the return product; however, they only plan to replace the product in an emergency situation, because they have very few of the 3/8" x 15mm adapters left and are looking to discontinue the 4040LC due to the discontinuance of this product by the manufacturer. If you have any questions, please contact (203) 458-0202 x 217.

Device

Bio Med Devices
  • Modèle / numéro de série
    Lot Numbers:  09072210 09081310, 09082510, 05091510
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: OH, WI.
  • Description du dispositif
    Bio Med Devices Disposable Pediatric Breathing Circuit, One Set || Catalog Number: 4040LC || 5 foot /15mm corrugated EVA hose || Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators
  • Manufacturer
    Biomed Devices

Manufacturer

Biomed Devices
  • Adresse du fabricant
    Biomed Devices, 61 Soundview Rd, Guilford CT 06437-2937
  • Source
    USFDA