Events

Rappel de Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector

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 B. Braun Medical Inc.

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
    34598
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0586-06
  • Date de mise en oeuvre de l'événement
    2006-02-06
  • Date de publication de l'événement
    2006-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44161
  • 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
    Container, I.V. - Product Code KPE
  • Cause
    B. braun medical has been notified by the manufacturer of the product (stedim) that a small percentage of the lots leak from the set port when the set port is opened. the leak was identified by stedim to be due to the incorrect placement of a septum in the set port. the set closure is intact and the leak remains internal until the set port is opened.
  • Action
    A recall notification letter was sent to the 22 customers who received the product between 12/1/05 and 1/11/06. The recall packages included a letter addressed to either the Director of Pharmacy/Director of Nursing, Materials Manager, or Distributor, as appropriate. They were mailed via US Post Office certified return receipt mail. Customers were instructed by letter to return all product at their facility to B. Braun Medical, Inc. in Breinigsville Pennsylvania. A Recall Information Form and a postage paid B. Braun Medical, Inc. return envelope were included in the recall package for the customer''s use.

Device

Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector
  • Modèle / numéro de série
    Lot Numbers: 05A14474, 05A18561, & 05A19926
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX
  • Description du dispositif
    B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
  • Manufacturer
    B. Braun Medical Inc

Manufacturer

B. Braun Medical Inc
  • Adresse du fabricant
    B. Braun Medical Inc, 2525 McGaw Ave, Irvine CA 92614-5841
  • Source
    USFDA