Events

Hospira GemStar Docking Station 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
    59470
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3107-2011
  • 사례 시작날짜
    2011-08-01
  • 사례 출판 날짜
    2011-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102851
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Hospira has received reports of sparking, smoking, charring and electrical shock when using the gemstar docking station due to fluid ingress into the docking station.
  • 조치
    Hospira Inc. sent an "URGENT DEVICE FIELD CORRECTION" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921. Contact Hospira at 1-800-441-4100 for questions concerning this notice. *** Hospira sent an update letter dated September 26, 2012 to the accounts, informing them of the availability of the improved design replacement docking stations, and requesting them to complete and return the enclosed reply via fax or e-mail to Hospira, indicating the number of docking stations to be returned for replacement at no charge if the old docking stations are returned within 45 days of receipt of the replacement stations. ***

Device

Hospira GemStar Docking Station
  • 모델명 / 제조번호(시리얼번호)
    List Number 13075-04-01, batch numbers 15047G1, 15048G1, 15050G1, 17100G1, 19140G1, 19142G1, 19157G1, 20165G1, 20180G1, 21183G1, 21196G1, 21197G1, 62001L2, 63001L2, 68002L2, 69002L2, 73002L2 and 78001L2; List Number 13075-04-03, batch numbers 26289G1, 27314G1, 27324G1, 30375G1, 34499G1, 34601G1, 34603G1, 34605G1, 34606G1, 34608G1, 35615G1, 40764G1, 40765G1, 40766G1 and 41804G1; List Number 13075-04-05, batch numbers 41802G1, 44848G1, 44854G1, 45879G1, 45879G101, 45879G1R, 45884G1, 46910G1, 47916G1, 47936G1, 48960G1, 51031G1, 51032G1, 60285G1, 84824G1, 84827G1, 84831G1 and 85844G1;  List number 13075-04-07, batch numbers 75679G1, 7698G1, 77698G101, 77715G1, 77715G101, 78734G1, 80774G1, 81784G1, 82789G1 and 87880G1;  List number 13075-24-01, batch numbers 10899G1, 10910G1, 10917G1, 10930G1, 14010G1, 15046G1, 16060G1, 19141G1, 19144G1, 19145G1, 19146G1, 19147G1, 19148G1, 19149G1, 20171G1, 21191G1, 21203G1, 26289G1, 64001L2, 68001L2, 69001L2, 71001L2 and 73001L2;  List number 13075-24-03, batch numbers 26289G1, 26294G1, 27325G1, 31397G1, 35620G1, 35621G1, 36634G1, 36636G1, 36638G1, 37667G1, 39739G1, 41786G1, 54114G1, 74001L2, 78002L2, 80001L2, 82001L2, 85308G1, 86319G1, 87340G1, 88358G1, 88366G1, 90442G1 and 92486G1; List number 13075-24-05, batch numbers 19141G1, 45878G1, 47915G1, 48961G1, 50020G1, 51021G1, 51022G1, 51028G1, 51030G1, 53081G1, 53082G1, 54098G1, 54113G1, 54114G1, 55125G1, 55126G1, 55135G1, 56158G1, 56170G1, 59230G1, 59231G1, 60258G1, 60272G1, 60284G1, 61307G1, 63318G1, 64345G1, 64354G1, 73634G1, 73636G1, 74647G1, 84828G1, 84828G1R, 84830G1 and 84830G1R;  List number 130752407, batch numbers 75680G1, 75681G1, 75682G1, 76686G1, 77694G1, 77694G1R, 77695G1, 77695G1R, 77696G1, 77697G1, 77712G1, 77712G1R, 77713G1, 77714G1, 78735G1, 78735G1R, 78736G1, 78736G1R, 78737G1, 80775G1, 80775G1R, 82799G1, 82799G1R, 82802G1, 82802G1R, 93962G1, 93962G1R, 94973G1, 94973G1R, 95981G1, 95981G1R, 95985G1, 95985G1R, 96004G1, 96004G1R, 96989G1, 96989G1R, 96996G1, 96996G1R, 97013G1, 97013G1R, 97017G1 and 97017G1R
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Jordan, the Netherlands, Portugal, Saudi Arabia, Singapore, Spain, Sweden and Switzerland.
  • 제품 설명
    GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only. || The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.
  • Manufacturer
    Hospira Inc.

Manufacturer

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