Events

Device Recall TEM Disposable Tube Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard Wolf Medical Instruments Corp. 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
    35845
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1430-06
  • 사례 시작날짜
    2006-07-07
  • 사례 출판 날짜
    2006-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47013
  • 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
    Transanal Endoscopic Microsurgery System insufflation rectal cavity - Product Code HIF
  • 원인
    The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
  • 조치
    Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same number.

Device

Device Recall TEM Disposable Tube Set
  • 모델명 / 제조번호(시리얼번호)
    Part Number 4170.801, Lot Number 060232
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
  • 제품 설명
    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • 제조사 주소
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • 제조사 모회사 (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA