Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Halyard Health 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
    69910
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0865-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-08-18
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • 원인
    The cuff inflation line may detach from the endotracheal tube during use.
  • 조치
    The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 13220, Lot numbers: AA3213, AA3227, AA3227V01, AA3245, AA3245V02, AA3253V02, AA3269V01, AA3274V01, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4104V02, AA4111V01, AA4113V01, AA4134V01 & AA4146V01, AA4146V04, AA4174V01.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
  • 제품 설명
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Halyard Health, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • 제조사 모회사 (2017)
  • Source
    USFDA