Events

Rappel de CORFLO 300 Enteral Pump

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 CORPAK MedSystems.

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
    59969
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0089-2012
  • Date de mise en oeuvre de l'événement
    2011-09-19
  • Date de publication de l'événement
    2011-10-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104131
  • 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, enteral - Product Code LZH
  • Cause
    Corpak is removing the corflo 300 enteral pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.
  • Action
    Corpak MedSystems sent Recall Notification letters dated September 19, 2011 to all CorFlo 300 Enteral Pump customers on the same date. The customers were informed that there is a possibility that with fluid ingress the keypad may become inoperable, and that there is a possibility of motor mount failure. Either event could possibly affect the rate at which formula is delivered to the patient, and fluid ingress could cause a potential of audible alarm failure. Corpak determined that the removal of the pumps from the market was the best option for their customers, and requested the return of all CorFlo 300 pumps to Corpak by no later than December 1, 2011. The customers were requested to contact Corpak at 1-800-323-6305 to arrange for the return of the pumps, and to complete and return the enclosed acknowledgement form, indicating the number of pumps on hand, via fax at 847-541-9526 or e-mail to questions@corpak.com. Dealers/distributors were requested to notify their customers of the recall.

Device

CORFLO 300 Enteral Pump
  • Modèle / numéro de série
    catalog 20-0500, all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. || Intended to deliver formula to patients requiring tube feedings.
  • Manufacturer
    CORPAK MedSystems

Manufacturer

CORPAK MedSystems
  • Adresse du fabricant
    CORPAK MedSystems, 100 Chaddick Dr, Wheeling IL 60090
  • Société-mère du fabricant (2017)
    Halyard Health Inc
  • Source
    USFDA