Events

Device Recall Single Shot Epidural Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. d.b.a. Integra Pain Management 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
    61525
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1943-2012
  • 사례 시작날짜
    2012-06-07
  • 사례 출판 날짜
    2012-07-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108353
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Anesthesia conduction kit - Product Code CAZ
  • 원인
    Integra lifesciences is recalling one lot of single shot epidural trays as the product was inadvertently shipped missing injectable components.
  • 조치
    Integra sent an Urgent - Medical Device Recall letter dated June 7, 2012, to one domestic consignee via Federal Express with a recall acknowledgement form followed up with a telephone call. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the Recall Acknowledgement Form including quantity of affected product in their inventory. Customers were also instructed to contact Integra Pain Management Customer Service to arrange for returns of all affected product. Product reconciliation will be performed to account for all affected products returned. Returned product will be reprocessed to correct for the missing components. Customers with questions were instructed to call Integra Pain Management Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-2311.

Device

Device Recall Single Shot Epidural Tray
  • 모델명 / 제조번호(시리얼번호)
    Lot W1112119
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including MA
  • 제품 설명
    Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. || The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management