Events

Rappel de Dual Luer Lock Cap

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
    66249
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0143-2014
  • Date de mise en oeuvre de l'événement
    2013-09-10
  • Date de publication de l'événement
    2013-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121842
  • 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
    Port, protector/cushion - Product Code OBK
  • Cause
    The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. particulate matter entering the fluid path from the luer lock caps may result in embolic events.
  • Action
    Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Device

Dual Luer Lock Cap
  • Modèle / numéro de série
    10043, 10044
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Canada.
  • Description du dispositif
    Dual Luer Lock Cap || The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
  • 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