Events

Device Recall Color Cuff 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    67040
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0630-2014
  • 사례 시작날짜
    2013-12-06
  • 사례 출판 날짜
    2014-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124590
  • 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
    Torniquet, pneumatic - Product Code KCY
  • 원인
    The color cuff¿ sterile disposable tourniquet cuffs with quick-connect fitting may have an incorrect end-connector. a customer reported having received a luer connector instead of a quick connect fitting. an incorrect connector may lead to an inoperable system due to incompatibility with the smart pump.
  • 조치
    Distributor was notified by E-mail 11/26/2013, with follow-up UPS letters sent to Hospital Risk/ Materials Managers identifying the product, reason for the recall, and risk. The notice asked consignees to find and quarantine all implicated product, with hospitals requested to complete the Business Reply Form and FAX to 866-521-2762. Stryker will email a pre-paid shipper and credit all accounts. Question and concerns should be addressed to Kelly Jo Whipple 269-389-2921 or kellyjo.whipple@stryker.com

Device

Device Recall Color Cuff
  • 모델명 / 제조번호(시리얼번호)
    Lot 50731155 Color code Purple
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution: including states of: MI, OH, and TX.
  • 제품 설명
    Stryker Color Cuff, REF 5921-034-135 || Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) || Single Bladder, Single Port, QuickConnect || Rx only, STERILE
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA