Events

Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits 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-01060-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01060-1
  • 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, the manufacturer mediplas identified an irregularity in the expandable tubing of specific batches of disposable expandable adult 22mmid expandable anaesthetic circuits. due to this, all remaining unused circuits from the affected batches will be replaced with unaffected product without any additional cost to the customer.
  • 조치
    Parker Healthcare is requesting that customers: 1. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact the 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. 2. Complete the Facsimile/Email Reply Form supplied with the customer letter within 5 business days, even if you no longer have affected product, as this information is required to reconcile this process. If any of the recalled products have been transferred to another facility, please immediately let them know of this Recall, and record it on the Facsimile/Email Reply Form.

Device

Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits
  • 모델명 / 제조번호(시리얼번호)
    Disposable Expandable Adult 22mmID Expandable Anaesthetic CircuitsPart Numbers:A3E120-700 - 120"/3m Length with Swivel Y AdaptorA3E120-102 - 120"/3m Length with Fixed Y Adaptor and Mask ElbowA3E120-100 - 120"/3m Length with Fixed Y Adaptor A3E240-700 - 240"/6m Length with Swivel Y Adaptor A3E120-702 - 120"/3m Length with Swivel Y Adaptor and Mask ElbowMultiple Batch/Lot NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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