Events

Angiotech Vascular Access Needle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Device Technologies, 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
    54688
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2018-2010
  • 사례 시작날짜
    2009-09-01
  • 사례 출판 날짜
    2010-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92380
  • 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
    trocar - Product Code DRC
  • 원인
    Medical device technologies doing business as angiotech has conducted a recall on angiotech breast localization needles, soft tissue biopsy needles, vascular access needles, bone biopsy needles, access needles, galactography kit, stabilization needles and needle guides for packaging integrity.
  • 조치
    Angiotech sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated September 1, 2009, to all customers. on September 2, 2009 by UPS 2nd day delivery with an assigned tracking number. The letter described the product, problem and action to be taken by customers. The customers were instructed to please review your current inventory and segregate the affected lot numbers, complete the attached Customer Acknowledgement Form and return via fax to our Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you are a distributor of this product, you are responsible for notifying any customer you may have sold the product to. If you have any questions concerning this notification, please contact Shannon Brooks at (352) 338-0440 ext.355 or Katrenia Williams at ext. 353.

Device

Angiotech Vascular Access Needle
  • 모델명 / 제조번호(시리얼번호)
    A) 90821TCC.   B) 90621SZO, 90981TPN, 91311UB7, 91391UHR, 90621T00, 91201U63, 91541URU .
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
  • 제품 설명
    Angiotech Vascular Access Needle. || A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. || B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended use: Vascular Access Needle
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.