Events

Rappel de Device Recall Temno

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 Carefusion 2200 Inc.

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
    56085
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2111-2010
  • Date de mise en oeuvre de l'événement
    2010-06-25
  • Date de publication de l'événement
    2010-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92609
  • 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
    Guide, needle, surgical - Product Code GDF
  • Cause
    The introducer needle is only 10 cm in length instead of the required 15 cm.
  • Action
    Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up "URGENT: PRODUCT RECALL" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion. If you have any questions, please contact 800-292-9332.

Device

Device Recall Temno
  • Modèle / numéro de série
    Catalog number CCH2220, Lot D09121745
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
  • Description du dispositif
    Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220 || For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Adresse du fabricant
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA