Events

Rappel de Device Recall Infusion Pump

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
    65364
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1609-2013
  • Date de mise en oeuvre de l'événement
    2013-06-07
  • Date de publication de l'événement
    2013-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118678
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Cause
    Due to an increase in complaints for leaks at the distal male luer and luer cap. baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer.
  • Action
    Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.

Device

Device Recall Infusion Pump
  • Modèle / numéro de série
    Product Code: 2C1073KJP  Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
  • Description du dispositif
    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device || Device Listing: D020871 || Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA