Events

Rappel de Device Recall McKesson MediPak Elastic Bandage, Premium, 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 Cypress Medical Products, Ltd..

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
    30550
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0368-05
  • Date de mise en oeuvre de l'événement
    2004-12-02
  • Date de publication de l'événement
    2004-12-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36090
  • 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, Elastic - Product Code FQM
  • Cause
    The elastic bandages which are labeled sterile have a lack of assurance of sterility.
  • Action
    Cypress Medical recalled the elastic bandages fro McKesson Medical-Surgical on 12/1/04 by telephone call and letter. McKesson was requested to sub-recall the product from their customers, which they did by letter dated 12/2/04.

Device

Device Recall McKesson MediPak Elastic Bandage, Premium, Sterile
  • Modèle / numéro de série
    Product Numbers 16-1033-2-STR, 16-1033-3-STR, 16-1033-4-STR, 16-1033-6-STR; lot numbers 3001 through 40999
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA.
  • Description du dispositif
    McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: || Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide
  • Manufacturer
    Cypress Medical Products, Ltd.

Manufacturer

Cypress Medical Products, Ltd.
  • Adresse du fabricant
    Cypress Medical Products, Ltd., 1202 S. Rte 31, McHenry IL 60050
  • Source
    USFDA