Events

Rappel de Device Recall Blue Belt Technologies

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 Blue Belt Technologies MN.

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
    65834
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1995-2013
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • Date de publication de l'événement
    2013-08-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120387
  • 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
    Drape, surgical - Product Code KKX
  • Cause
    Blue belt technologies is recalling sterile monitor drapes used with their navio pfs system during orthopedic knee surgery. the drapes are used to cover the navio pfs system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. the defect is evident when the computer monitor is being draped. the front section of the drape separates from the rest of the drape at.
  • Action
    Blue Belt Technologies contacted consignees by telephone using a script on July 19, 2013. The consignees were informed of the problem and the product involved in the recall. Consignees were advised to immediate stop using the product and to locate and quarantine all unused product. Additionally, an "Urgent Medical Device Recall" letter dated July 24, 2013 was issued on July 24, 2013 and August 12, 2013. The letter includes the description of the Issue, description of safety concerns, affected product, and action to be taken by user. For questions contact Blue Belt Technologies, Lindsey Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.

Device

Device Recall Blue Belt Technologies
  • Modèle / numéro de série
    Lot: D130432, expires February 2018
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
  • Description du dispositif
    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. || Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
  • Manufacturer
    Blue Belt Technologies MN

Manufacturer

Blue Belt Technologies MN
  • Adresse du fabricant
    Blue Belt Technologies MN, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA