Events

Device Recall Four Lead TUR Irrigation Set, UROMATIC Plastic Contaners. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare 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
    65183
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1682-2013
  • 사례 시작날짜
    2013-05-15
  • 사례 출판 날짜
    2013-07-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118153
  • 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
    System, irrigation, urological - Product Code LJH
  • 원인
    A firm's internal investigation led to the discovery of pinholes in the packaging of the products. the pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
  • 조치
    Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com

Device

Device Recall Four Lead TUR Irrigation Set, UROMATIC Plastic Contaners.
  • 모델명 / 제조번호(시리얼번호)
    UR175554 UR176743 UR182030 UR188144 UR192047 UR192096 UR192260 UR194951 UR202044 UR204032 UR211698 UR214312 UR216069 UR222471 UR225334 UR229294 UR233569 UR233700 UR238915 UR243022 UR246009 UR249383 UR255802 UR260273 UR262980 UR263004 UR265918 UR283580 UR287284 UR288746 UR298216 UR304246 UR307249 UR314328 UR318063 UR321000 UR325464 UR334151 UR339317 UR344234 UR352484 UR352567 UR360255 UR363432 UR366161 UR375857 UR383794 UR385534 UR07J19029 UR07K29059 UR07L21039 UR08B21053 UR08C25151 UR08E15157 UR08G22167 UR08I12065 UR08K13086 UR08L18158 UR09A21211 UR09D02157 UR09E14084 UR09G17125 UR09H26140 UR09J30040 UR09J30065 UR09J30107 UR09L01146 UR10C25033 UR10D09142 UR10E21037 UR10G28129 UR10I28034 UR10L03024 UR10L22024 UR11A14022 UR11B24086 UR11B25125 UR11C25032 UR11F01028 UR11G08088 UR11H08011 UR11H09019 UR11I08043 UR11I23026 UR12A25043 UR12E18502 UR12H03011 UR12H17045 UR12I05030 UR12I06053 UR12I21052 UR12J18040 UR12J26019 UR12L12023 UR13B08053 UR13B15041 UR13C08036
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) || Usage: || Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA