Events

Device Recall PHS Spinal Tray 24G Gertie Marx 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
    75029
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2868-2016
  • 사례 시작날짜
    2016-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149139
  • 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 has recently identified that one lot of spinal tray 24 g gertie marx catalogue # 899379 was shipped containing the 24 g gertie marx needle without an introducer.
  • 조치
    Consignees notified on 8/24/16 via an Urgent - Field Corrective Action letter e-mail. The letter identified the affected device and the reason for the recall. Customers were asked to review their inventory of the Spinal Tray 24 G Gertie Marx to confirm the quantity received. The attached form should be completed and returned by e-mail or fax as indicated. Once the form is received, Customer Service will place an order for the customer to receive replacement devices. Questions should be directed to Customer Service at 1-800-241-2210.

Device

Device Recall PHS Spinal Tray 24G Gertie Marx
  • 모델명 / 제조번호(시리얼번호)
    Lot Number affected: W1503532
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to CA.
  • 제품 설명
    PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. || Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

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