Events

Device Recall Sizing Balloon II 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGA Medical Corporation 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
    57819
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1595-2011
  • 사례 시작날짜
    2010-12-17
  • 사례 출판 날짜
    2011-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97502
  • 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, intravascular occluding, temporary - Product Code MJN
  • 원인
    Aga medical is initiating a voluntary recall of a specific lot of mislabeled amplatzer sizing balloon ii. aga medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. the proper sizing (24 mm) was printed on the device hub visible through the product package.
  • 조치
    AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA. For questions regarding this recall call 1-763-531-3175.

Device

Device Recall Sizing Balloon II
  • 모델명 / 제조번호(시리얼번호)
    Lot 10004282114
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom
  • 제품 설명
    AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. || The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • 제조사 주소
    AGA Medical Corporation, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA