Various Disposable Catheter Mounts 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Swirl Technologies Pty Ltd T/A Parker Healthcare 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
    RC-2017-RN-01268-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-04
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Parker healthcare are recalling the affected stock due to a potential obstruction within the swivel elbow adaptor. if component is obstructed, it would restrict the gas flow to the patient and may lead to serious health consequences. two incidents of faulty catheter mounts have been reported. however, to date, no injuries have occurred.
  • 조치
    Parker Healthcare are advising users to inspect stock and quarantine any affected units. Affected stock can be returned to Parker for replacement with unaffected product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Various Disposable Catheter MountsDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 15MPart Number: 6000-40(D)Disposable Catheter Mount Dble Swvl Elbw w Suction Port & Adaptor 15M SterilePart Number: 6000-40(D)/SDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 22FPart Number: 6000-41(D)Double Swvl Elbw w Suction Port and Cap 15mmM to 22mmM/15mmF Sterile PPPart Number: PH71522/SMultiple Batch NumbersARTG Number: 188096
  • Manufacturer