Events

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-2251-2011
  • 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
    United States
  • Date de fin de l'événement
    2012-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98170
  • 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 irrigation procedure trays contain triad group alcohol prep pads recalled by triad group because they have the potential to be contaminated with an objectionable organism.
  • 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

Device Recall WELCON
  • Modèle / numéro de série
    Lot codes: 812083, 901041, 904254, 907192, 908039, 911228, 912190, 1003293, 1004168, and 1005018
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • 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. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Product Label: REORDER NO. 6101 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6031, R1 WELCON BRAND SINGLE USE Standard Irrigation Tray With Clear-Vu Bulb Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFree CONTENTS: 1200 mL Graduated Drain Tray 500 mL Graduate Bulb Syringe Waterproof Underpad Prep Pad Protective Cap || Intended use: The trays are irrigation trays for catheters
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

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