Events

Imager II Angiographic Catheter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific Pty Ltd 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-2016-RN-01654-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01654-1
  • 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
    Boston scientific has received a field report noting that some units within a certain lot were missing the bottom pouch seal that forms part of the sterile barrier. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. although boston scientific has confirmed that only one batch (00112758) was missing a bottom seal, as a precautionary measure, they are notifying all customers of this issue that received batches processed through this alternate label reprint process. on affected product, the compromised seal is completely missing and is obvious to the user. the device can be readily exchanged resulting in an insignificant prolongation in the medical procedure. to date there have been no reports of patient injury associated with a missing pouch seal.
  • 조치
    Boston Scientific is advising customers to post the customer letter that details the issue in a visible location near the product to ensure all users are aware of the issue. Users are to immediately discontinue use of and segregate any inventory missing a bottom pouch seal, and then return it to Boston Scientific. Credit will be issued for returned stock. This action has been closed-out on 27/06/2017.

Device

Imager II Angiographic Catheter
  • 모델명 / 제조번호(시리얼번호)
    Imager II Angiographic Catheter Various Material Numbers (UPNs) and Batch NumbersExpiry date range: 1 April 2018 - 31 July 2018ARTG Number: 137897
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA