Events

Rappel de Device Recall Baxter Combined Epidural Anesthesia Trays

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
    34381
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0508-06
  • Date de mise en oeuvre de l'événement
    2006-01-10
  • Date de publication de l'événement
    2006-02-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43873
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • Cause
    The bd catheter connector contained in the epidural anesthesia trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
  • Action
    Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Combined Epidural Anesthesia Trays
  • Modèle / numéro de série
    product code 1T5771, lot GD822783;  product code 2T2076, lot GD822932;  product code 2T2097, lot GD822940;  product code 2T2201, lot GD822817;  product code 2T2215, lot GD822825;
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Baxter Combined Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing a spinal needle, an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the spinal needle or epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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