Events

Device Recall Stryker SmartPump Extension Tubing 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
    59791
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-3274-2011
  • 사례 시작날짜
    2011-08-25
  • 사례 출판 날짜
    2011-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103747
  • 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
    Accessories for Pneumatic Tourniquet - Product Code KCY
  • 원인
    Three complaints have been reported indicating that the product inside the package did not match the label description. the units had quick connectors instead of luer lock connectors as stated in the label description.
  • 조치
    Stryker Instruments sent out "Urgent Medical Device Recall" notices dated August 22, 2011 to all affected customers. The letter included the name of the recalled product, lot numbers, and the reason for the recall. Customers were instructed to send back any product to Stryker that is within the affected lots. The letter further stated Stryker will quarantine the product and replace any product that is returned. For information on this recall contact Stryker Instruments at (269) 389-4534.

Device

Device Recall Stryker SmartPump Extension Tubing
  • 모델명 / 제조번호(시리얼번호)
    60" Part number 5920-000-003; lot number 11137012. 40" Part number 5920-000-005; lot number 11138012.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE
  • 제품 설명
    Stryker SmartPump Extension Tubing (Pneumatic tourniquet). || Sterile tubing extension 40" and 60", set, luer lock. Rx only. || Stryker Instruments Div. of Stryker Corporation. || Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.
  • 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