Events

Rappel de Device Recall DISP. HYPODERMIC NEEDLE

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 Terumo Medical Corporation.

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
    58863
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2798-2011
  • Date de mise en oeuvre de l'événement
    2010-06-08
  • Date de publication de l'événement
    2011-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100438
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Cause
    Hypodermic needle packaging defect could compromise sterility. affected lot numbers are: mc1725, mc2025, mc2025.
  • Action
    The firm, Terumo Medical Corporation sent an "URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a "Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall DISP. HYPODERMIC NEEDLE
  • Modèle / numéro de série
    Catalog Number 431, Catalog Number 443, Catalog Number 100280
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA
  • Description du dispositif
    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. || Product Usage: Aspiration and injection of fluids for medical purposes.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Adresse du fabricant
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA