Rappel de Device Recall Microtek Medical, Inc., Microscope Drape for Zeiss Standard

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
    56864
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0592-2011
  • Date de mise en oeuvre de l'événement
    2010-08-23
  • Date de publication de l'événement
    2010-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2010-12-14
  • 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
    Surgical Drape and Drape Accessories - Product Code KKX
  • Cause
    This product is being recalled due the product is miss-labeled as being sterilized by eo processing; however, the product was processed using gamma sterilization.
  • Action
    On 08/23/10 Microtek Medical, Inc., Jacksonville, Florida notified all of their customers via a telephone call and requested immediate return of the product . The firm followed up with each of the customers by sending out an Urgent: Medical Device Recall letter (written notice), dated September 02,2010, to each on 9/8/10. The letter identified the affected product, stated the reason for the recall, and asked that the product be returned immediately. Customers are to complete and return the enclosed response form. Anyone needing further assistance is asked to contact Elizabeth Jolly, V.P. Legal at 1-888-844-0988.

Device

  • Modèle / numéro de série
    Lot Number: DA102032 Expiration Date: 2015-07
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Microtek Medical, Inc., Microscope Drape for Zeiss Standard || Model/Catalog Number: 70890655 || Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to protect surgical microscopes from contamination during various procedures. || Labeling for the product is as follows: || (1.) INNER CARTON LABEL: || Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)30748426064206, (17) 150700(10) DA102032, INNER, Rev. C. || (2.) PRODUCT LABEL: || Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 1, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01) 00748426064205, (17) 150700(10) DA102032, EACH, Rev. D. || (3.) CARTON LABEL: || Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12/CS, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)50748426084200, (17) 150700(10) DA102032, INNER, Rev. D.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Microtek Medical, Inc., 7022 A C Skinner Pkwy, Suite 290, Jacksonville FL 32256-6944
  • Source
    USFDA