Events

Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Swivel Elbow 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-01168-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01168-1
  • 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
    During a regular qa inspection, parker healthcare noticed an irregularity in the expandable tubing of specific tube/mask breathing circuit single-use connectors (disposable catheter mounts). to date, no injury or illness has been reported.
  • 조치
    1. Complete and return the supplied acknowledgement form. If any of the affected products have been transferred from your facility to another, immediately inform other supplied facilities of this Recall. 2. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. Returned stock will be replaced with unaffected batches at no cost.

Device

Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Sw...
  • 모델명 / 제조번호(시리얼번호)
    Various Disposable Catheter MountsStraight SwivelSwivel ElbowStraight AdaptorsElbowDouble Swivel ElbowMultiple Product Names, Part Numbers and Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA