Events

Rappel de SmartPump Tourniquet Pump

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 Stryker Instruments Div. of Stryker Corporation.

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
    56624
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0912-2011
  • Date de mise en oeuvre de l'événement
    2010-04-13
  • Date de publication de l'événement
    2011-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94404
  • 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
    Tourniquet, pneumatic - Product Code KCY
  • Cause
    This recall is related to the electi-cord recall. there is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. over time the fracture may lead to arcing inside of the molded sction of the plug and a build up of heat which can cause charring, electric shock or fire. to this date there have been zero complaint for this fa.
  • Action
    Stryker Instruments sent an Urgent - Medical Device Recall Notification letter dated April 13, 2010, to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Stryker notified customers again on May 24, 2010, and again on September 14, 2010, via email, fax, or telephone. Customers were instructed to locate the units and visually inspect each affected cord. Remove the affected cord and dispose of it using their healthcare facilities disposal procedure. If the cord did not show signs of damage, the unit could remain in service until a replacement cord was available. Customers were to return the enclosed business reply form to confirm receipt of the notification letter and identify how many affected units were currently in their inventory. Stryker instruments would send out replacement cords. If the customer loaned or sold any of the units listed in the notification, the customer was to forward a copy of the notice to the new users and advise Stryker of the new user's name and their new location. If products were disposed of and were no longer in use, the customer was to advise Stryker of their obsolescence by providing them with their serial numbers. For questions regarding this recall call 800-800-4236, ext 3808 or ext 3584 Monday -Friday 8am-5pm (EST).

Device

SmartPump Tourniquet Pump
  • Modèle / numéro de série
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  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England.
  • Description du dispositif
    Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF 5920-011-000, Rx only. || Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA