Events

Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Thomas Medical Products 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
    57679
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1228-2011
  • 사례 시작날짜
    2010-12-16
  • 사례 출판 날짜
    2011-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97485
  • 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
    vascular interventional device - Product Code DQY
  • 원인
    Compromised sterility/weak or open seals.
  • 조치
    GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.

Device

Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve
  • 모델명 / 제조번호(시리얼번호)
    Contamination Sleeve part no. CON-006-02, lot no. S32943; Acuity Bleedback Control Valve part no. CSP-001-00, lot no. Z0000040; Acuity Rotating Hemostasis Valve part no. CSP-002-01, lot no. Z0000036; Acuity Universal Cutter part no. CSP-003-00, lot numbers Z0000038 and Z0000039; Acuity Universal Cutter part no. CSP-003-01, lot number Z0000054.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution Nationwide USA and Germany.
  • 제품 설명
    Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contamination Sleeve part no. CON-006-02; Acuity Bleedback Control Valve part no. CSP-001-00; Acuity Rotating Hemostasis Valve part no. CSP-002-01; Acuity Universal Cutter part no. CSP-003-00; Acuity Universal Cutter part no. CSP-003-01.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • 제조사 주소
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA