Events

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

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microtek Medical, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    56864
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0592-2011
  • 사례 시작날짜
    2010-08-23
  • 사례 출판 날짜
    2010-12-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94684
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Surgical Drape and Drape Accessories - Product Code KKX
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: DA102032 Expiration Date: 2015-07
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    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.
  • 제조사 주소
    Microtek Medical, Inc., 7022 A C Skinner Pkwy, Suite 290, Jacksonville FL 32256-6944
  • Source
    USFDA