Events

Integra Cranial Access Kit 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.

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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
    66186
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2260-2013
  • 사례 시작날짜
    2013-09-04
  • 사례 출판 날짜
    2013-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121671
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HGB
  • 원인
    Integra is recalling certain lots of cranial access kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
  • 조치
    Integra sent an Urgent Voluntary Medical Device Recall letter dated September 4, 2013, to all affected customers that have been shipped unexpired affected product lots of Integra¿ Cranial Access Kits, Catalogue No.'s INSHITH, INSHITHND, INSHITHRZN.The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review their inventory and immediately stop the use or distribution of any affected product. Customers were instructed to identify and report to Integra if they do or do not have any of the affected product lots. Customers were advised how to return any affected product lot numbers in their possession. Effectiveness Checks will be conducted to determine the level of customers who: - Integra has verified, have been notified, and / or acknowledged the recall either by returning the acknowledgement form. - Indicate they will be returning / have returned unexpired affected product lots of kits. Any affected product lot numbers that are returned from consignees will be forwarded to the Integra Salt Lake City, UT facility for final disposition per its site QMS processes. Customers with questions were advised to contact Customers Service at 1-855-532-1723. For questions regarding this recall call 801-886-9505.

Device

Integra Cranial Access Kit
  • 모델명 / 제조번호(시리얼번호)
    INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
  • 제품 설명
    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN || The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

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