Events

Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles 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
    72775
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0417-2016
  • 사례 시작날짜
    2015-11-23
  • 사례 출판 날짜
    2015-12-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142281
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    The guidewire introducer needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. there is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
  • 조치
    Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921

Device

Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles
  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including PA and SC.
  • 제품 설명
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) || 20 units per case || The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
  • 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