Device Recall ARC DISASTER KIT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lifeline First Aid LLC 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
    60041
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0120-2012
  • 사례 시작날짜
    2011-07-07
  • 사례 출판 날짜
    2011-10-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-29
  • 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
    First aid kit with drug - Product Code LRR
  • 원인
    The first aid kits are recalled because the kits contain iodine prep pad single use wipes which were recalled by triad.
  • 조치
    Lifeline First Aid, LLC sent a " PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P; Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721. Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.

Device

  • 모델명 / 제조번호(시리얼번호)
    no codes.
  • 의료기기 분류등급
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, || The kit is labeled in parts: "***American Red Cross***Item 7201*** || 2 IODINE PREP PADS***Produced by the American Red Cross***Oregon Trail Chapter***503-528-5848***PO Box 3200, Portland, OR 97208***www.RedCross.org***". || First aid kit.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 301, Wilsonville OR 97070-8204
  • Source
    USFDA