Events

Rappel de Device Recall Baxter Sabraset 6060 Set with Preattached 250 mL Bag

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
    31969
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1086-05
  • Date de mise en oeuvre de l'événement
    2005-05-04
  • Date de publication de l'événement
    2005-08-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38833
  • 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, Intravascular - Product Code FPA
  • Cause
    The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
  • Action
    Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.

Device

Device Recall Baxter Sabraset 6060 Set with Preattached 250 mL Bag
  • Modèle / numéro de série
    product code 560500-250, lots 417521, 418481, 418744
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Australia, Belgium, Canada and Japan.
  • Description du dispositif
    Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA