Device Recall Catheter Introducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biocardia, 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
    67712
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1302-2014
  • 사례 시작날짜
    2014-03-03
  • 사례 출판 날짜
    2014-03-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-06-19
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Firm discovered the potential for particulates in the inner lumen of morph access pro steerable introducer, which could result in am embolic event.
  • 조치
    The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number MAP690 -lot numbers:  1051  1063  1083  1106  1119  1137  1138  1140  1146  1148  1151  1154  1160  1162  1183  1186
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and country of: Israel.
  • 제품 설명
    Morph AccessPro Steerable Introducer; || 6F Introducer, 90 cm working length: || Single use only. || BioCardia, Inc. || San Carlos, CA 94070 || BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Biocardia, Inc., 125 Shoreway Rd Ste B, San Carlos CA 94070-2718
  • 제조사 모회사 (2017)
  • Source
    USFDA