Events

Rappel de Device Recall Quick Connect

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 Steris 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
    65138
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1596-2013
  • Date de mise en oeuvre de l'événement
    2013-03-04
  • Date de publication de l'événement
    2013-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118047
  • 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
    Sterilant, medical devices - Product Code MED
  • Cause
    During a routine label review, the firm identified four system 1e quick connects that will be updated to reflect the removal of obsolete device models. this labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
  • Action
    STERIS sent a Customer Notification letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to replace their existing labels with labels they provided in their customer notification package. We apologize for any inconvenience this may have caused you and as always STERIS Corporation is dedicated to support our products and valued Customers. If you have any questions regarding this matter, please contact your STERIS Capital Account Manager. For further questions please call (440)392-7348

Device

Device Recall Quick Connect
  • Modèle / numéro de série
    LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
  • Description du dispositif
    Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 || QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Adresse du fabricant
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Société-mère du fabricant (2017)
    Steris Corporation
  • Source
    USFDA