Events

Rappel de Device Recall FREEDOMAIRE(R) MOTOR MODULE

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 Microtek Medical 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
    70721
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1338-2015
  • Date de mise en oeuvre de l'événement
    2015-03-10
  • Date de publication de l'événement
    2015-03-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134545
  • 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
    Gown, surgical - Product Code FYA
  • Cause
    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 cfr 801.437; it does not contain caution: the packaging of this product contains natural rubber latex which may cause allergic reactions.
  • Action
    The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: recall@ecolab.com RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; customerservice@microtekmed.com.

Device

Device Recall FREEDOMAIRE(R) MOTOR MODULE
  • Modèle / numéro de série
    Lot Numbers: C11049, C11076, C12339, C13063, C13091, C13109, C13218, C13364
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) Distribution.
  • Description du dispositif
    FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX || The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
  • Manufacturer
    Microtek Medical Inc

Manufacturer

Microtek Medical Inc
  • Adresse du fabricant
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Société-mère du fabricant (2017)
    Ecolab Inc
  • Source
    USFDA