Device Recall STERRAD 50 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    51413
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1419-2009
  • 사례 시작날짜
    2009-03-09
  • 사례 출판 날짜
    2009-06-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-14
  • 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
    Ethylene Oxide Gas Sterilizer - Product Code FLF
  • 원인
    Asp has identified a secondary, lower-occurring cause of oil mist within certain sterrad nx systems and sterrad 50 systems due to potentially defective oil fill plugs.
  • 조치
    Firm mailed out Urgent Device Correction letters dated March 9, 2009, advising customers/users that on April 23, 2008, Advanced Sterilization Products (ASP) initiated a device correction notification related to certain models of STERRAD Sterilization Systems that have the potential to emit oil mist due to a premature mechanical failure in the oil mist filter and/or filter assemblies. All affected STERRAD Systems have been corrected since the notification was issued. Recently, a secondary, lower-occurring cause of oil mist has been identified within the STERRAD NX System and STERRAD 50 System oil fill plugs. STERRAD NX System and/or STERRAD 50 System may potentially have defective oil fill plugs. Less than 1% of the installed STERRAD NX Systems have been affected. ASP has received 18 complaints in 10 months related to this failure for the STERRAD NX System. No complaints related to this issue for the STERRAD 50 System have been received. As of December 22, 2008, ASP has been actively replacing the plugs in these systems with stainless steel plugs during service calls and will continue to replace the oil fill plugs until all affected units are corrected. The letter advises that there is a risk of symptoms, such as nausea, shortness of breath, dry throat, burning, watery and blurry eyes, and headache occurring if customers inhale oil mist. If you see mist, haze or smoke in the room or detect an oil odor, personnel should complete the following: - Cancel the cycle if the sterilizer is running and as always, do not use instruments from an incomplete cycle - Leave the room - Avoid working in the room until the mist has cleared - Discontinue use of the STERRAD System until the system is repaired. Any additional questions can be directed to the Clinical and Technical Support staff at 1-888-4613.

Device

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
  • 제품 설명
    STERRAD 50 Sterilization System Product Code 10050 || The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • 제조사 모회사 (2017)
  • Source
    USFDA