Events

Rappel de Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

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 Arizant 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
    54487
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0895-2010
  • Date de mise en oeuvre de l'événement
    2009-12-17
  • Date de publication de l'événement
    2010-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88575
  • 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
    system, thermal regulating - Product Code DWJ
  • Cause
    Arizant healthcare inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (arizant part number 502221 model 90024) attached to its temperature management units and pressure infusion power pack (bair paws¿ temperature management units: models 850 and 875 bair hugger¿ temperature management units: models 500/or, 505 (human & vet.), 750 (human & vet) and 775 ranger¿ blood/flui.
  • Action
    An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.

Device

Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
  • Modèle / numéro de série
    Part number 502221 Model 90024
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.
  • Description du dispositif
    Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. || To provide power to pressure infusers.
  • Manufacturer
    Arizant Inc

Manufacturer

Arizant Inc
  • Adresse du fabricant
    Arizant Inc, 10393 W 70th St, Eden Prairie MN 55344
  • Source
    USFDA