Events

Pinnacle Cure Sleeve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Metrex Research, LLC. 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
    63583
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0444-2013
  • 사례 시작날짜
    2011-09-20
  • 사례 출판 날짜
    2012-11-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114255
  • 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
    Cover, barrier, protective - Product Code MMP
  • 원인
    The firm initiated the recall due to a labeling error. the boxes labeled as pinnacle cure sleeve 4511, which fits 11mm light guides, actually contain pinnacle cure sleeves that fit 7mm or 8mm light guides (part number 4500).
  • 조치
    The firm, Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 20, 2011 to its consignees/customers. The consignees/customers were instructed to determine if they have any of the affected product in their inventory; if they have the affected product to contact Metrex Research Customer Care at 1-800-841-1428 to receive an RMA number; return any affected product in their inventory; and complete and return the Recall Response Form via mail to: Metrex Research, 29210 Wick Road, Romulus, Michigan 48174, Attn: QA Lab or fax to: 734-947-6725. If you have any questions regarding this recall, you can contact our Customer Care Center at 1-800-841-1428.

Device

Pinnacle Cure Sleeve
  • 모델명 / 제조번호(시리얼번호)
    Part Number Lot Number  4511 201008270110
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
  • 제품 설명
    Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier || The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
  • Manufacturer
    Metrex Research, LLC.

Manufacturer

Metrex Research, LLC.
  • 제조사 주소
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA