Device Recall Stryker Scope Warmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Endoscopy 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
    56110
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2622-2010
  • 사례 시작날짜
    2010-06-21
  • 사례 출판 날짜
    2010-09-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-12-16
  • 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
    Laparoscope, general; plastic surgery - Product Code GCJ
  • 원인
    Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
  • 조치
    Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model number 502-360-000, all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
  • 제품 설명
    Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
  • Source
    USFDA