Device Recall 3M Micropore Paper Tape 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company / Medical Division 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
    54640
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1418-2010
  • 사례 시작날짜
    2010-01-29
  • 사례 출판 날짜
    2010-04-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 Tape - Product Code KGX
  • 원인
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • 조치
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.

Device

  • 모델명 / 제조번호(시리얼번호)
    200902XE 200902XK
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution, and Puerto Rico.
  • 제품 설명
    3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
  • Manufacturer

Manufacturer

  • 제조사 주소
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • 제조사 모회사 (2017)
  • Source
    USFDA