Events

Device Recall Integra Small Rickham Style Reservoir 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    67025
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0621-2014
  • 사례 시작날짜
    2013-11-13
  • 사례 출판 날짜
    2014-01-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124551
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    Integra became aware through an adverse complaint trend that rickham style reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open.
  • 조치
    Integra sent an Urgent Voluntary Medical Device Recall letter dated November 13, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located stop using immediately. Customers were asked to complete the attached form and return it to Integra as indicated and keep a copy of the form for their records. Once the form was received by Integra they will send an RMA number, directions to return the product, and input an order to replace the quantity they indicated on the form. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 855-532-1723.

Device

Device Recall Integra Small Rickham Style Reservoir
  • 모델명 / 제조번호(시리얼번호)
    1091271, 1094671, 1104165, 1104631, 1104813, 1110404, 1120638, 1120816, 1122316, 1123940, 11311659, 1132989, 1133427
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
  • 제품 설명
    Integra Small Rickham -Style Reservoir || Rx Only Sterile for Single Use Only || Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA || NL 850-1121 || Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.