Events

Rappel de Allegiance Esmark 6" x 108" Bandage, Latex Free, Sterile

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 International Medsurg Connection, 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
    36169
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1529-06
  • Date de mise en oeuvre de l'événement
    2006-08-16
  • Date de publication de l'événement
    2006-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48119
  • 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
    Bandage - Product Code MHW
  • Cause
    The bandages labeled as sterile had not been sterilized prior to distribution.
  • Action
    International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hospitals were requested to contact Cardinal Customer Service at 800-964-5227 to arrange for product return and credit or replacement of all product. All other customers were directed to call 1-888-444-5440 for product return and replacement. All questions were directed to Cardinal Quality Systems at 800-292-9332 or Mr. Manny Gupta at International Medsurg Connection at 847-619-9929.

Device

Allegiance Esmark 6" x 108" Bandage, Latex Free, Sterile
  • Modèle / numéro de série
    Catalog 24593-063A, lot 06-1990-1
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Allegiance Esmark 6' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-063A
  • Manufacturer
    International Medsurg Connection, Inc.

Manufacturer

International Medsurg Connection, Inc.
  • Adresse du fabricant
    International Medsurg Connection, Inc., 935 N Plum Grove Rd Ste F, Schaumburg IL 60173-4770
  • Société-mère du fabricant (2017)
    International Medsurg Connection Inc.
  • Source
    USFDA