Events

Device Recall VASCUGUARD Pheripheral Vascular Patch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synovis Surgical Innovations, 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
    71191
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1637-2015
  • 사례 시작날짜
    2015-05-02
  • 사례 출판 날짜
    2015-05-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136433
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • 원인
    Baxter healthcare is recalling specific product codes of vascu-guard peripheral vascular patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
  • 조치
    The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.

Device

Device Recall VASCUGUARD Pheripheral Vascular Patch
  • 모델명 / 제조번호(시리얼번호)
    all lot numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • 제조사 주소
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA