Events

Rappel de Device Recall B. Braun addEASE Binary 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
    56164
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0306-2011
  • Date de mise en oeuvre de l'événement
    2010-06-24
  • Date de publication de l'événement
    2010-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92791
  • 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
    I.V. Fluid Transfer Set - Product Code LHI
  • Cause
    During this insertion, fragmentation of the pab container stopper may occur resulting in a small amount of visible particulates in the solution.
  • Action
    On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility. Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.

Device

Device Recall B. Braun addEASE Binary Connector
  • Modèle / numéro de série
    Lot Numbers:  60928513, 60936541, 60936543, 60942059, 60950900, 60953588, 60969534, 60972173, 60973280, 60983742, 60997643, 61003958, 61017469, 61027183, 61027186, 61031167, 61031168, 61042196, 61045157, 61056656, 61057867, 61058745, 61073202, 61078826, 61085625, 61096650, 61102775, 00VL907673, 00VL907677, 00VL912573, 00VL927133, 00VL927134, and 00VL927135.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Description du dispositif
    B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) || Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
  • 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