Events

Rappel de Device Recall B. Braun

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
    67172
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0921-2014
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • Date de publication de l'événement
    2014-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124860
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Cause
    Internal testing of two lots of the accuflo ct-2000-100 elastomeric infusion pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.
  • Action
    B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization and any consignees your organization may have are informed of this recall. If you are a distributor, please forward this recall notice to any customers who are in receipt of the impacted product. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Recall Acknowledgement" form record the number of full cases and individual units (for any loose units or partial cases) in your possession. If you have no inventory, please indicate that you have zero (0) inventory on the "Recall Acknowledgement" form. 5. Return the completed "Recall Acknowledgement" form to B. Braun Medical Inc. Quality Assurance who will administer the recall on behalf of B. Braun Melsungen AG. The form must be e-mailed to PA_QualityAssurance.BBMUS.Service@bbraun.com or faxed to (610) 849-1197 within two (2) weeks of receipt even it the inventory in your possession is zero. 6. Instructions for Credit, Replacement, Et Return: a.If you have purchased the product from a third-party and have any full cases, partial cases, or unused individual pieces in your possession please contact the seller to obtain instructions for handling these units. b.If you have purchased the product directly from B. Braun Medical Inc. and have any full cases, partial cases, or unused individual pieces of these affected products, ple

Device

Device Recall B. Braun
  • Modèle / numéro de série
    Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution one importer/wholesale distributor in MO.
  • Description du dispositif
    B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML || Generally used for delivery of antibiotic and local anesthesia medications.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA