Events

Rappel de Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set

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 Sustainability Solutions.

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
    72715
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0478-2016
  • Date de mise en oeuvre de l'événement
    2015-11-17
  • Date de publication de l'événement
    2016-01-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142020
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Cause
    Stryker sustainability solutions is recalling the fuhrman pleural & pneumopericardial drainage set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
  • Action
    The firm, Stryker Sustainability Solutions, sent a "URGENT MEDICAL DEVICE RECALL" letter dated 11/17/2015 to its customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to discontinue the use of the product, and complete the Recall Effectiveness Check Form even if no product has been found in inventory. Customers should return the completed Recall Effectiveness Check Form to their local Stryker Sustainability Sales Representative, email to ssspfa@stryker.com, or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive,Tempe, AZ 85283. If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have any questions, contact Senior Regulatory Affairs Specialist at (888) 888-3433x5506 or email: chelsea.cullen@stryker.com.

Device

Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set
  • Modèle / numéro de série
    Item Number G03974  Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
  • Description du dispositif
    The Fuhrman Pleural/Pneumopericardial Drainage Set || The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Adresse du fabricant
    Stryker Sustainability Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA