Events

Rappel de 12 Instrument Sterilization Tray

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 Endoscopy.

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
    68045
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1544-2014
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Date de publication de l'événement
    2014-05-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126854
  • 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
    Electrosurgical, cutting & coagulation & - Product Code GEI
  • Cause
    Gravity sterilization parameters provided in the 12 instrument sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
  • Action
    Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to endorecall@stryker.com. For questions call 1-800-624-4422 option 3 or via email at endorecall@stryker.com.

Device

12 Instrument Sterilization Tray
  • Modèle / numéro de série
    Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1,  48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1,  36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129,  43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476,  43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542,  41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1,  51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1,  37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1,  48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445,  42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843,  42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610,  43893-1-13, 39219, 43893-1-2, 43893-1-14.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution
  • Description du dispositif
    12-Instrument Sterilization Tray; || Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA