Rappel de Device Recall Welcon

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 Nurse Assist, 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
    58021
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2280-2011
  • Date de mise en oeuvre de l'événement
    2011-01-20
  • Date de publication de l'événement
    2011-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
  • Cause
    The trays contain triad group sterile lubricating jelly packs recalled by triad group because of the possibility of inadequate sterilization.
  • Action
    The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.

Device

  • Modèle / numéro de série
    Lot Codes: 808118
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Description du dispositif
    Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 7502 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 French Red Rubber Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 14 French Red Rubber Catheter Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad || Intended use: The trays are urological catheter trays.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Société-mère du fabricant (2017)
  • Source
    USFDA