Events

Rappel de Device Recall Medline Angio Drape Pack RadiologyLF

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 Medline Industries 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
    63739
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0568-2013
  • Date de mise en oeuvre de l'événement
    2012-11-08
  • Date de publication de l'événement
    2012-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114684
  • 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
    General surgery tray (kit) - Product Code LRO
  • Cause
    The non-sterile waste bag component in the custom pack was attached to the outside of the pack in its own packaging. the product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
  • Action
    The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.

Device

Device Recall Medline Angio Drape Pack RadiologyLF
  • Modèle / numéro de série
    Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: New York only.
  • Description du dispositif
    Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D || This custom pack includes components necessary for a specific procedure.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA