Events

100 mL Hemovac Mini Evacuator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Surgical 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
    71057
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1610-2015
  • 사례 시작날짜
    2015-04-21
  • 사례 출판 날짜
    2015-05-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135958
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • 원인
    Devices were placed in a shipper carton without the appropriate number of the instructions for use (ifu). packaging specifications require that each sales unit is accompanied by an ifu. only one ifu was present in the shipper carton, instead of one ifu per each of the two sales units.
  • 조치
    On 4/28/2015 the firm sent Urgent: Medical Device Removal letters to their customers. The letters identified the affected product in addition to stating that the reason for the recall is due to missing Instructions for Use from sales units. The letters discussed the clinical implications or risk to health, and actions required. Customers are to review the notification, identify and quarantine the affected product to prevent further distribution or use, and return the completed response form to CorporateQuality.PostMarket@zimmer.com and the affected product to the address provided. A credit will be issued for unused devices upon receipt. Questions regarding this information should be directed to 330-364-0989.

Device

100 mL Hemovac Mini Evacuator
  • 모델명 / 제조번호(시리얼번호)
    Item #00-2568-000-10; Lot #62800843
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
  • 제품 설명
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. || Intended for post-operative collection of wound drainage.
  • Manufacturer
    Zimmer Surgical Inc

Manufacturer

Zimmer Surgical Inc
  • 제조사 주소
    Zimmer Surgical Inc, 200 W Ohio Ave, Dover OH 44622-9642
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA