Events

Device Recall OptiSeal Valved PTFE Peelable Introducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greatbatch Medical 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
    56281
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2294-2010
  • 사례 시작날짜
    2010-07-02
  • 사례 출판 날짜
    2010-08-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93135
  • 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 outer sterile barrier (pouch) packaging for the 12 fr device is not intact. no breaches in the inner sterile barrier (tray/tyvek lid) have been identified. the optiseal introducer and accessories sealed in the tray are sterile. infection may result if a sterile field is contaminated by the outer surface of the inner tray.
  • 조치
    Greatbatch Medical issued an "Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702.

Device

Device Recall OptiSeal Valved PTFE Peelable Introducer
  • 모델명 / 제조번호(시리얼번호)
    Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: United States, including the states of MN and CA.
  • 제품 설명
    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • 제조사 주소
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • 제조사 모회사 (2017)
    Integer Holdings Corporation
  • Source
    USFDA