Events

Rappel de Device Recall 8400 Capnocheck Capnometer

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 Smiths Medical PM, 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
    54360
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0920-2010
  • Date de mise en oeuvre de l'événement
    2010-01-15
  • Date de publication de l'événement
    2010-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88331
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    Smiths medical is conducting a voluntary recall of a limited number of medical device ac power cords, manufactured by electri-cord manufacturing co., for use with bci 3180 pulse oximeter(human), 9200 advisor vital signs monitor(human or veterinary), 8400 capnocheck ii capnometer(human or veterinary) and v6400 invasive pressure monitor (veterinary). the affected electri-cord ac power cords are eq.
  • Action
    Consignees were sent a Smiths Medical PM, Inc letter dated January 12, 2010 starting on 1/15/10. The letter was addressed to Risk/Safety Managers, Distributors, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists, and Nursing, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem and products involved. It provided "Advice on Action to be Taken by the User" and requested the return of the "Urgent Recall Notice Confirmation Form." Customers are advised to monitor affected equipment. To return Power Cords, for questions regarding this Urgent Recall Notice, or to report any issues with these Power Cords, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.

Device

Device Recall 8400 Capnocheck Capnometer
  • Modèle / numéro de série
    Power cord # 8404.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI, WY. Worldwide distribution: Trinidad and Tobago, Mexico, Taiwan, Ecuador, Norway, Colombia, Brazil, France, Japan, Canada.
  • Description du dispositif
    8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Adresse du fabricant
    Smiths Medical PM, Inc., N7 W22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA