Events

Rappel de Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

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 STERILMED, 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
    69337
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0059-2015
  • Date de publication de l'événement
    2014-10-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130259
  • 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
    Reprocessed intravascular ultrasound catheter - Product Code OWQ
  • Cause
    Sterilmed, a division of johnson & johnson medical nv/sa (sterilmed), has become aware of an issue affecting certain lots of reprocessed soundstar® eco diagnostic ultrasound catheters for which sterilmed is the reprocessor and biosense webster is the distributor. sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne.
  • Action
    Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.

Device

Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
  • Modèle / numéro de série
    Lot Numbers: 1717945, 1721574, 1721575 and 1723123  Catalog Nos: M-5723-115, Model Number BIO10438577
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of WA and CA.
  • Description du dispositif
    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
  • Manufacturer
    STERILMED, INC.

Manufacturer

STERILMED, INC.
  • Adresse du fabricant
    STERILMED, INC., 11400 73rd Ave N, Maple Grove MN 55369-5561
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA