Events

Centurion Healthcare Products Arthrogram Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tri-State Hospital Supply Corporation 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
    46155
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0730-2008
  • 사례 시작날짜
    2007-10-26
  • 사례 출판 날짜
    2008-02-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66907
  • 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 Disposable Instrument - Product Code KDC
  • 원인
    Incorrect needle size - some of the kits contain a 1 inch 21g needle instead of the 1-1/2 inch 21 needle specified on the kit label.
  • 조치
    An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.

Device

Centurion Healthcare Products Arthrogram Tray
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 907097.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, including states of Massachusetts and Washington.
  • 제품 설명
    Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.
  • Manufacturer
    Tri-State Hospital Supply Corporation

Manufacturer

Tri-State Hospital Supply Corporation
  • 제조사 주소
    Tri-State Hospital Supply Corporation, 301 Catrell Drive, Howell MI 48843
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA