Events

Device Recall Vaxcel 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
    55786
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1882-2010
  • 사례 시작날짜
    2010-05-13
  • 사례 출판 날짜
    2010-07-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91836
  • 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
    port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • 원인
    Fda testing determined that non-coring needles included in the vaxcel port and vaxcel port with pasv valve may result in coring and resulting septum damage which could lead to patient injury.
  • 조치
    Navilyst Medical, Inc. is recalling Vaxcel Ports and Vaxcel Ports with PASV Valve with valid expiration dates worldwide. Navilyst sent "Urgent Medical Device Recall - Immediate Action Required" letter/recall notification packages on May 13, 2010, via Federal Express to 471 domestic consignees; on May 14, 2010, via e-mail to 14 international consignees and to Boston Scientific Corporation (prior owner of the affected products) via facsimile and Federal Express. On June 3, 2010, Navilyst Medical sent Recall Notification Packages on behalf of Boston Scientific Corp. via Federal Express to 182 domestic consignees. The letter instructs the customer to immediately discontinue use of and segregate recalled product, complete and return the reply verification tracking form to fax# 518-742-4450 and package and return the recalled product to the address provided. If you have any question, please call Navilyst Medical, Inc., Customer Service at 1-800-833-9973 or Michael Duerr at 1-518-742-4571.

Device

Device Recall Vaxcel
  • 모델명 / 제조번호(시리얼번호)
    Lots 1263713, 1267693, 1283243, 1287605, 1292865, 1299860, 1302380, 1309262, 1310743, 1319164, 1323675, 1357022, 1372173
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • 제품 설명
    Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • 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