Events

Device Recall Alaris Extension Sets with Microbore Tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 303, 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
    80093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2111-2018
  • 사례 시작날짜
    2017-11-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164545
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Reports of incorrect priming volume due to manufacturing with incorrect tubing.
  • 조치
    The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support Center,10020 Pacific Mesa Blvd, San Diego CA 92121, by FAX: 1-858-617-4851 or by EMAIL: SupportCenter@bd.com. Note on the card your distributors name and quantities that will be returned. " Once BD receives the Recall Response Card, the BD Support Center will provide instructions for return of the affected lot numbers and replacement of the affected lots. " " All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods processed through their distributor if the products were purchased through a distributor. " " Your distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the BD Support Center at the number listed below." A second letter was sent on May 2018 adding an additional lot # for Alaris Extension Set with microbore tubing Model number 30914 lot number 17097167 Recall Related Questions BD Support Center Phone: 1-888-562-6018 Hours: 7am to 4pm PST, Monday -Friday Email: SupportCenter@carefusion.com

Device

Device Recall Alaris Extension Sets with Microbore Tubing
  • 모델명 / 제조번호(시리얼번호)
    Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
  • 제품 설명
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 || Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • 제조사 주소
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA