Events

BD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Company 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
    69604
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0572-2015
  • 사례 시작날짜
    2014-10-09
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131025
  • 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,therapeutic,short-term less than 30 days - Product Code FOZ
  • 원인
    Bd insyte autoguard may have potential damage along the body of the catheter.
  • 조치
    BD sent an 'Urgent:Voluntary Product Recall Letters/Notice of Return ' dated October 9, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, quarantine the affected product, and return all affected product with the completed Notice of Return form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue a credit. Customers who do not have of the affected product were also asked to complete the Notice of Return form indicating (0) quantity and return form back to BD by fax to 1-201-847-6990. If the product was further distributed customers were instructed to identify their customers and notify them at once of the product recall. Customers with questions were instructed to call 201-847-4267.

Device

BD
  • 모델명 / 제조번호(시리얼번호)
    Distributed in USA   REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17  REF 381434 20 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min  Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17  Distributed outside of USA  REF# 381833 20G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min Lot4143917, May -17  REF 3811834 20 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min  Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.
  • 제품 설명
    BD Insyte Autoguard Catheter || An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA