Device Recall Lifeshield burette set. 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
    54079
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1329-2010
  • 사례 시작날짜
    2009-11-24
  • 사례 출판 날짜
    2010-04-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-01-29
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Intravascular Administration Set - Product Code FPA
  • 원인
    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
  • 조치
    Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 561245H, 590405H, 591205H, 591275H, 591485H, 601115H, and 621025H.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • 제품 설명
    Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 100 inch with 2 pre-pierced injection sites, SOLUSET, MICRODRIP, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL 60045 USA. made in Costa Rica, list number 11398-20.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045-2513
  • 제조사 모회사 (2017)
  • Source
    USFDA