Device Recall HeaterBaum Foot & Ankle Heating Pad 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ergoactives, 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
    74078
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2137-2016
  • 사례 시작날짜
    2016-01-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Pad, heating, powered - Product Code IRT
  • 원인
    Products are marketed without a cleared 510k.
  • 조치
    Customers were notified by phone on 01/19/2016. Two follow-up notifications were sent to customers via e-mail. Customers were asked to immediately examine their inventory for the affected product; and, to notify and identify any customers they may have further distributed to. Ergoactives LLC requests that all Heaterbaum products be sent back to their headquarters: 20725 NE 16th Avenue, Suite A-26, Miami, FL 33179, along with the order number and note of where the product was purchased. The enclosed response form should be completed and returned as well. If customers have any questions, they can call Ergoactives LLC at (305)359-5031. Customers will receive a full refund for the return of their Heaterbaum products.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots; UPC: 862821000030.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.
  • 제품 설명
    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ergoactives, Llc, 20725 NE 16th Ave Ste A26, Miami FL 33179-2132
  • 제조사 모회사 (2017)
  • Source
    USFDA