Events

Rappel de Device Recall 5C4160 Transfer Set with Spike Connector

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 Baxter Healthcare Corp..

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
    64928
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2474-2015
  • Date de mise en oeuvre de l'événement
    2013-02-25
  • Date de publication de l'événement
    2015-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117443
  • 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
    Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Cause
    Labeling revision: additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
  • Action
    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to fca@baxter.com. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Device

Device Recall 5C4160 Transfer Set with Spike Connector
  • Modèle / numéro de série
    Product Code: 5C4160; All Lots
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
  • Description du dispositif
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. || intended for use with containers of DIANEAL peritoneal dialysis solution.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA