Events

Device Recall WARM AIR WARMING UNIT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero 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
    53947
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0781-2010
  • 사례 시작날짜
    2009-11-14
  • 사례 출판 날짜
    2010-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86906
  • 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
    System, thermal regulating - Product Code DWJ
  • 원인
    Product is labeled as "sterile". it was observed that incomplete seals were created in the packaging materials during production. when the seal is compromised, the sterility of the product inside the package cannot be assured.
  • 조치
    On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.

Device

Device Recall WARM AIR WARMING UNIT
  • 모델명 / 제조번호(시리얼번호)
    Product # 82542; Catalog # 542; Lot #: 07279, 07280, 07424 & 08813.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
  • 제품 설명
    FilteredFlo¿ Cardiac Blanket. || The device is used to distribute heated air around a patient (for patient warming).
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA