Events

Rappel de Presource Custom Sterile Surgical and Procedure Kits

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
    60069
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0170-2012
  • Date de publication de l'événement
    2011-11-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104381
  • 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
    Tray, surgical - Product Code LRP
  • Cause
    Some of the components contained in the presource kits are being recalled because cardinal health has determined that the component manufacturers do not have all necessary fda registrations or filings needed for these components.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. 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 pack/modules labeled. For component credit, the consignees were instructed to contact Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above. For questions regarding this recall call 800-292-9332.

Device

Presource Custom Sterile Surgical and Procedure Kits
  • Modèle / numéro de série
    all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin
  • Description du dispositif
    Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Adhesive Remover Wipes, component 050-0415; || b) Perineze Perineal Witch Hazel Pad, component 505040A || c) 24" Infant Tape Measure, component 30942P; || d) Triple Dye Drug, 10 unit dose, component PM1022; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.
  • 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