Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microtek Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0592-2011
  • Event Initiated Date
    2010-08-23
  • Event Date Posted
    2010-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94684
  • Notes / Alerts
    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.
  • Extra notes in the data
    Surgical Drape and Drape Accessories - Product Code KKX
  • Reason
    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

Device Recall Microtek Medical, Inc., Microscope Drape for Zeiss Standard
  • Model / Serial
    Lot Number: DA102032 Expiration Date: 2015-07
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
    Microtek Medical, Inc.

Manufacturer

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