Events

Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beaver-Visitec International 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
    79908
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1539-2018
  • 사례 시작날짜
    2018-02-26
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163908
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    Incorrect tip was used during manufacturing of the osher thermodot marker. the markers have a needle tip instead of the proper flat tip.
  • 조치
    On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.

Device

Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20  UDI: 30886158014899
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of OH, NY, FL, MN, and KS.
  • 제품 설명
    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. || Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
  • Manufacturer
    Beaver-Visitec International Inc.

Manufacturer

Beaver-Visitec International Inc.
  • 제조사 주소
    Beaver-Visitec International Inc., 411 Waverley Oaks Rd Ste 229, Waltham MA 02452-8422
  • 제조사 모회사 (2017)
    Tpg Capital Management L.P.
  • Source
    USFDA