Events

Rappel de BD

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Becton Dickinson & Company.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75150
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0394-2017
  • Date de mise en oeuvre de l'événement
    2016-08-02
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149465
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Anesthesia conduction kit - Product Code CAZ
  • Cause
    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.
  • Action
    BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016. Stericycle is handling returns.

Device

BD
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    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
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA