Receptal Liners 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira Inc. 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
    66448
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2594-2016
  • 사례 시작날짜
    2013-09-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-12-15
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • 원인
    Hospira has become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 1.5 l liner, 2l liner or 3l liner with a 1l canister. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
  • 조치
    URGENT MEDICAL DEVICE RECALL letters dated September 10, 2013 were distributed to direct accounts notifying them of the recall. The letter requests that customers to ensure that they only use liners and canisters of corresponding sizes (e.g. a 1000mL liner with a 1000mL canister) and to only use Hospira components. The letter further advises customers of an ongoing recall of the 1000mL Receptal systems. Customers were requested to complete and return the attached reply form and to notify other healthcare providers within their organization.Customers who further distributed the Receptal systems were requested to forward the letter to their customers and to request that the contact Stericycle at 1-888-943-5175 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to obtain a reply form.

Device

  • 모델명 / 제조번호(시리얼번호)
    43001-04-01 43023-04-01 43024-04-01 43024-04-62 43025-04-01 43025-04-11 43025-04-21 43025-04-25 43027-04-01 43027-04-05 43027-04-11 43027-04-14 43027-04-17 43031-04-02 43032-04-05 43034-04-06 43036-04-04 43037-04-02 43038-04-04 43038-04-05 43041-04-01 43042-04-01 43042-04-11 43043-04-01 43044-04-01 43044-04-05 43044-04-11 43044-04-15 43044-04-51 43046-04-01 43046-04-05 43047-04-01 43056-04-01 43061-04-01 43062-04-01 43063-04-01 43064-04-01 0L212-01 0L213-01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
  • 제품 설명
    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) || 1) List Number 43056-01; || 2) List Number 43023-01; || 3) List Number 43025-01; || 4) List Number 43025-11; || 5) List Number 43025-21; || 6) List Number 43025-25; || 7) List Number 43038-05; || 8) List Number 43043-01; || 9) List Number 43044-01; || 10) List Number 43044-11; || 11) List Number 43046-01; || 12) List Number 43047-01; || 13) List Number 43041-01; || 14) List Number 43024-01; || 15) List Number 43027-01; || 16) List Number 43027-14; || 17) List Number 43001-01; || 18) List Number 43064-01; || 19) List Number 43046-05; || 20) List Number 43042-11; || 21) List Number 43042-01; || 22) List Number 43044-05; || 23) List Number 43044-15
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA