Events

Rappel de Device Recall Baxter Clearlink System Buretrol Solution 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 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
    53751
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0487-2010
  • Date de mise en oeuvre de l'événement
    2009-11-03
  • Date de publication de l'événement
    2009-12-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86463
  • 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 tubing may separate from the distal clearlink y-site of the set, which could result in patient injury if the separation occurs during patient use.
  • Action
    An "Urgent Product Recall" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement product by calling Baxter Healthcare Center for Service at 1-888-229-0001, Prompt 2, during hours of operation 7:00 a.m. to 6:00 p.m. Central Standard Time. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. If the accounts further distributed the Buretrol Sets, they were requested to forward the communication to those accounts. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter.

Device

Device Recall Baxter Clearlink System Buretrol Solution Set
  • Modèle / numéro de série
    Product code 2C8864; Lot number UR09E21238.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.
  • Description du dispositif
    Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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