Events

Rappel de Device Recall HEPFLUSH

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 Fresenius Kabi USA, LLC.

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
    70050
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1032-2015
  • Date de mise en oeuvre de l'événement
    2014-12-19
  • Date de publication de l'événement
    2015-01-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132221
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Cause
    The lot failed ph specification.
  • Action
    Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at http://www.fresenius-kabi.us /products/pharmaceutical-products/product-updates.html. 2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi. 3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630. Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.

Device

Device Recall HEPFLUSH
  • Modèle / numéro de série
    Lot 6005501, Exp. Date 1/2016
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
  • Manufacturer
    Fresenius Kabi USA, LLC

Manufacturer

Fresenius Kabi USA, LLC
  • Adresse du fabricant
    Fresenius Kabi USA, LLC, 3 Corporate Dr, Lake Zurich IL 60047-8930
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA