Events

Device Recall Large Bore Central Venous Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    52376
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1671-2009
  • 사례 시작날짜
    2009-05-08
  • 사례 출판 날짜
    2009-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82808
  • 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
    Central Venous Catheters - Product Code FOZ
  • 원인
    Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
  • 조치
    The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.

Device

Device Recall Large Bore Central Venous Catheters
  • 모델명 / 제조번호(시리얼번호)
    Product number AK-12123-H - Lot numbers: RF8045004, RF8072289, RF8084254, RF8107640, RF8108841, RF8110482, RF8122717, RF9027113, RF9030981; Product number CS-12123-E - Lot numbers: RF8032041, RF8043417, RF8058142, RF8060023, RF8072220, RF8084333, RF8097145, RF8109080, RF8110116, RF9015982, ZF7126427, ZF8027168, ZF8027448, ZF8037862, ZF8048194, ZF8048672, ZF8059197, ZF8069577, ZF8090983, ZF8091196, ZF8101854, ZF8102010, ZF8112852, ZF8124161, ZF9014366, ZF9025408, ZF9035840, ZF9046856; Product number MA-12123 - Lot numbers: ZF8027407, ZF8059146, ZF8090984, ZF9014354, ZF9046854; and  Product number MC-12123 - Lot numbers: RF8057141 and RF8083743.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
  • 제품 설명
    12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. || The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA