Events

Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Orthobiologics, 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
    62834
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0431-2013
  • 사례 시작날짜
    2012-07-26
  • 사례 출판 날짜
    2012-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111813
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • 원인
    When preparing plasma using vitaprep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. firm has since discovered that if blood is present in the luer connection of the vitaprep following the blood draw step, this blood could be displaced to the outside of the syringe when the vitaprep cap is reattached to the syringe. t.
  • 조치
    Stryker sent a "MEDICAL DEVICE FIELD CORRECTION" dated July 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.

Device

Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat
  • 모델명 / 제조번호(시리얼번호)
    Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV
  • 제품 설명
    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. || Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
  • Manufacturer
    Stryker Orthobiologics, Inc.

Manufacturer

Stryker Orthobiologics, Inc.
  • 제조사 주소
    Stryker Orthobiologics, Inc., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA