Events

Rappel de Device Recall Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sit

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
    53955
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0684-2010
  • Date de mise en oeuvre de l'événement
    2009-11-24
  • Date de publication de l'événement
    2010-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87295
  • 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
    Intravascular administration set - Product Code FPA
  • Cause
    System error 9 alarms. a system error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). this alarm is generated during the pumps initiation sequence and will not allow the set to be used. this requires a new set to be obtained, thus creating a potential for delay in therapy.
  • Action
    The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.

Device

Device Recall Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2...
  • Modèle / numéro de série
    Product Code 375150. Lot numbers: 61030891 exp 3/31/2012, 61033511 exp 3/31/2012, 61057278 exp 5/31/2012, 61063529 exp 6/30/2012, and 61070195 exp 6/30/2012.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
  • Description du dispositif
    Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

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