Events

Rappel de JacksonPratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only.

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 200, LLC.

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
    77127
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2140-2017
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • 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=155235
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Cause
    Product's seal possibly compromised, potentially compromising the sterility of the package contents. use of impacted products could result in an increased risk of infection.
  • Action
    CardinalHealth sent an Urgent Product Recall letter dated April 21, 2017, to all affected customers (including response firm). Customers were instructed to inspect recalled lots and return any affected product found. Distributors were instructed to notify their customers. Affected product will be destroyed. To arrange for return of any affected product by contacting Customer Service at the following numbers: Hospital800.964.5227 Distributor800.635.6021 Federal Government800.444.1166 All Other Customers888.444.5440 Customers with questions were instructed to contact Cardinal Health Customer Advocacy at 800-292-9332. For questions regarding this recall call 847-887-4138.

Device

JacksonPratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only.
  • Modèle / numéro de série
    Catalog Number: SU130-0521 Lot Numbers: 1161481 1170193 1170194
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Adresse du fabricant
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA