Events

Rappel de Device Recall T/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 Medical Division 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
    79302
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1013-2018
  • Date de mise en oeuvre de l'événement
    2017-11-07
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161846
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Cause
    The t/pump operations manual and maintenance manual were incorrectly revised to add the sentence, temperature therapy can also be for heat conservation for normothermia maintenance to the indications for use statement.
  • Action
    The following actions are included in the consignee letter: 1. Locate the operations (101515 rev D.0) and maintenance (101176 rev F.0) manuals that accompanied the units listed on the attached business reply form. 2. Find the corrected pages included in this letter and insert one into each affected manual at your location. 3. Complete the enclosed business reply form to acknowledge that you have received and understand this notification. 4. Return your completed business reply form by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers regulatory department. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form.

Device

Device Recall T/Pump

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA