PACEMAKER PACK 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MEDLINE CANADA CORPORATION 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
    21521
  • 사례 위험등급
    III
  • 사례 시작날짜
    2017-01-23
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Medline industries received a product advisory notice from bd concerning their eclipse needle. bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. the bd eclipse needle is a component in several medline custom procedure packs. medline canada is therefore informing its customers of the bd advisory notice.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: DYNJ52472X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46890X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46856X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46726X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46729X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46858X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46877X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46859X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46745X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48513X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900660X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46835X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46860X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41876X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46736X (Lot serial: CONTACT MFG); Model Catalog: CDS982078X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48536X (Lot serial: CONTACT MFG); Model Catalog: DYNJ37224X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41910X (Lot serial: CONTACT MFG); Model Catalog:
  • 제품 설명
    PACEMAKER PACK;TVT WCH-LF;SHOULDER RVHS-LF;VAG HYS ANT PST REPAIR TEGH-LF;C SECTION TEGH-LF;MINOR PROCEDURE RVHS-LF;BREAST BIOPSY WCH-LF;MAJOR LIMB RVHS-LF;PACEMAKER TEGH-LF;ENDONASAL DCR MSH-LF;TMJ MSH-LF;C SECTION SJHC-LF;MINOR LIMB RVHS-LF;ANGIOGRAM LF
  • Manufacturer

Manufacturer