Events

Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Navilyst Medical, 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
    60775
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0648-2012
  • 사례 시작날짜
    2011-02-04
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106450
  • 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
    Catheter, biliary, diagnostic - Product Code FGE
  • 원인
    Navilyst medical, inc. determined that the exodus standard loop biliary drainage catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
  • 조치
    The firm, Navilyst Medical, sent an "Urgent Medical Device Recall -Immediate Action Required" letter dated February 4, 2011, via Federal Express to the domestic consignees/customers and one foreign consignee/customer. Consignees/customers were instructed to: (1.) Immediately discontinue use and remove the recalled product from inventory; (2.) Segregate this product in a secure location for return to Navilyst Medical, Inc.; (3.) Immediately forward a copy of the recall notification to ALL sites to which they have distributed affected device (4.) promptly complete and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to: QA Manager, Navilyst Medical, Inc., 1-800-782-1357; (5.) call Customer Service at 1-800-833-9973 between 8:30.am to 7:00pm EST to obtain RMA number; (6.) package and return the recalled product; and (7.) Physicians were instructed to continue to monitor their patients and evaluate per institutional protocol for biliary catheters. If you have any questions about this recall action, your local Sales Representative is available to assist you or contact QA Manager, Navilyst Medical, Inc., directly at 518-742-4571.

Device

Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating
  • 모델명 / 제조번호(시리얼번호)
    Lots 1ML0060705, 1ML0070901, 1PD0040501
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AK, AZ, CA, CO, FL, IL, KS, MI, MO, NC, NJ, NY, OH, OK, PA, PR and country of: South Africa.
  • 제품 설명
    Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. || Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • 제조사 주소
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • 제조사 모회사 (2017)
    Navilyst Medical, Inc
  • Source
    USFDA