Events

Rappel de Device Recall CystoCare Coloplast

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-2288-2011
  • 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=98857
  • 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

Device Recall CystoCare Coloplast
  • Modèle / numéro de série
    Lot Codes: 803221, 1003053, 1004329, 1007026, 906225, 907301, and 910221.
  • 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: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark || Tray Label: Cysto-Care Coloplast REF: UT8145 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays. || Intended use: The trays are urological catheter trays.
  • 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