Events

Device Recall Lifeline Brand 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
    74329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2132-2016
  • 사례 시작날짜
    2016-05-16
  • 사례 출판 날짜
    2016-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147206
  • 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
    Valve, non-rebreathing - Product Code CBP
  • 원인
    First aid kits or rescue kits are recalled because they contains the cpr shield with one way valve and barrier filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (otc) use.
  • 조치
    The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.

Device

Device Recall Lifeline Brand
  • 모델명 / 제조번호(시리얼번호)
    item #4042 and item #4043 have the expiration date: 11/30/2017.  Item #4037 has the following lots and expiration dates: Lot # Expiration Date 101483; 3/15 101546; 6/15 101682; 7/15 101804; 1/16 101812; 1/16 102032; 5/16 102109; 5/16 102098; 5/17 102130; 5/16 102296; 10/16 102317; 10/16 102295; 10/16 102372; 1/17 102638; 1/17 102694; 8/17
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.
  • 제품 설명
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. || Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. || UPC Red color kit: 845174005464; || UPC Lime color kit: 845174005594; || UPC Purple color: 845174005600; || UPC of master case of 6 845174005471 (2 each color) || Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • 제조사 주소
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 302, Wilsonville OR 97070-8204
  • 제조사 모회사 (2017)
    Lifeline First Aid Llc
  • Source
    USFDA