Events

Device Recall American Surgical 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Surgical Company 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
    73734
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1738-2016
  • 사례 시작날짜
    2016-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144929
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • 원인
    Product packaging defective compromising sterility.
  • 조치
    American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: CustomerService@AmericanSurgical.com

Device

Device Recall American Surgical
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers:  2015/09 AY 2015/11 AA 2015/12 BB
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
  • 제품 설명
    American Surgical Ultracot 5 mm x 13 mm (Glassine) || Ref Number: 23-02G || Product Usage: || Neurosurgical and Nonneurosurgical Sponges
  • Manufacturer
    American Surgical Company

Manufacturer

American Surgical Company