Events

Rappel de MediVac NonConductive Suction Tube

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 Cardinal Health.

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
    56563
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2452-2010
  • Date de mise en oeuvre de l'événement
    2010-08-16
  • Date de publication de l'événement
    2010-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93973
  • 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
    Tubing, noninvasive - Product Code GAZ
  • Cause
    The packaging seals may not be intact, resulting in compromised sterility for the listed medi-vac non-conductive tubing.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated August 16, 2010 to consignees, identifying the reason for the recall, the affected lots, and actions to be taken. Cardinal has inspected all packages in their warehouses and removed the affected products. All packages that have been inspected have a 3/4" green dot on the front of each unit and on the case carton label. " Cardinal Health end users were instructed to segregate and destroy their affected product and request credit or replacement " Distributor customers were instructed to destroy their product and request credit or replacement " Distributors were instructed to conduct sub-recalls and return their inventory to Cardinal Health " To arrange for credit or replacement of the product destroyed, the accounts were instructed to call customer service at 800-964-5227 or 888-444-5440. " All customers were requested to complete the enclosed Recall Acknowledgment Form acknowledging receipt of the letter and the number of tubing units destroyed, and fax it to 847-689-9101. Cardinal Health can be contacted at 800-292-9332. Cardinal sent recall letters dated 8/26/10 to their PreSource kit/module customers via UPS next day air, informing them that the Medi-Vac Non-conductive Suction Tubing listed may have packaging seals that are compromised. The accounts were informed that Cardinal has inspected tubing packages in their warehouses and removed the affected products. All packages that have been inspected will have a 3/4" green dot on the front of each package. Enclosed with the recall letter were recall labels to affix to each affected Presource pack/module in the account's inventory. These labels instruct the user NOT to use the affected tubing component and to remove and discard the component upon opening the kit. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of packs/modules on hand. Distributo

Device

MediVac NonConductive Suction Tube
  • Modèle / numéro de série
    All lots prior to Y10Kxxxx
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, including USA.
  • Description du dispositif
    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N712 and NEX712 (European label)
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Adresse du fabricant
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA