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
    75150
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0394-2017
  • 사례 시작날짜
    2016-08-02
  • 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=149465
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • 원인
    A recall was initiated by hospira, inc. for several lots of 5% lidocaine hci and 7.5% dextrose injection, usp, 2ml ampul, ndc # 0409-4712-01. some bd" spinal trays contain the 5% lidocaine hydrochloride and 7.5% dextrose injection, usp, 2ml ampul (ndc number 0409-4712-01) being recalled by hospira. as a result, bd is initiating a recall for the affected bd spinal trays.
  • 조치
    BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016. Stericycle is handling returns.

Device

BD
  • 모델명 / 제조번호(시리얼번호)
    25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B03H034D 1-May-2015 B04J262D 1-Oct-2016   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H034D 1-May-2015 B01H238D 1-Jan-2016 B01H259D 1-Jan-2016 B02J229D 1-Oct-2016 B03J364D 1-Oct-2016 B03K006D 1-Oct-2016 B03K048D 1-Oct-2016 B04H136D 1-Sep-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H035D 1-May-2015 B01H036D 1-May-2015 B01H070D 1-Jun-2015 B01H091D 1-Jun-2015 B01H138D 1-Sep-2015 B02H031D 1-May-2015 B04H119D 1-Jun-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H191D 1-Oct-2016 B02H135D 1-Oct-2016 B03H050D 1-Jul-2016 B03H114D 1-Oct-2016   27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B02H034D 1-May-2015   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) B03H153D 1-Sep-2015   27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    catalog # 405612 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405622 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405623 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405624 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405634 || BD Spinal Anesthesia Tray || 26G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405636 || BD Spinal Anesthesia Tray || 26G x 3.5 in. BD" Quincke Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405641 || BD Spinal Anesthesia Tray || 24G x 3.5 in. Sprotte¿ Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405648 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Whitacre Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog# 405649 || BD Spinal Anesthesia Tray || 22G x 3.5 in. BD" Whitacre Spinal Needle || 25G x 3.5 in. BD" Quincke Spinal Needle || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog # 405682 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405684 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405685 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog#405694 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Quincke Spinal Needle || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405704 || BD Spinal Anesthesia Tray || 27G x 3.5 in. BD" Whitacre Spinal Needle || Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL || catalog #405737 || BD Spinal Anesthesia Tray || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW || Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) || catalog# 405829 || BD Spinal Anesthesia Tray || 27G x 3.5 in. BD" Quincke Spinal Needle || 25G x 3.5 in. BD" Whitacre Spinal Needle, TW
  • 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