StatLock IV Premium Catheter Stabilization Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems Inc. 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
    77132
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2120-2017
  • 사례 시작날짜
    2017-04-25
  • 사례 출판 날짜
    2017-05-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-08-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Device, intravascular catheter securement - Product Code KMK
  • 원인
    Statlocktm iv premium catheter stabilization device may contain an incorrectly sized retainer clip.
  • 조치
    Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number JUAQF675, Exp 2/28/2019
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
  • 제품 설명
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Bard Access Systems Inc., 605 N 5600 W, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
  • Source
    USFDA