Events

Rappel de Device Recall BD SurePathTM Preservative Collection Vials

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 & Co..

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
    75886
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0877-2017
  • Date de mise en oeuvre de l'événement
    2016-02-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151578
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Cause
    Bd has confirmed that a portion of bd surepath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
  • Action
    BD Life Sciences sent the initial recall notification on February 12, 2016. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. For further questions, please call (410) 316-4000.

Device

Device Recall BD SurePathTM Preservative Collection Vials
  • Modèle / numéro de série
    SurePath Collection Vial Replacement Cap, cat no. 490505 SurePath GYN Preservative Vial Kit, cat no. 490527 SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095 SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096 SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product
  • Description du dispositif
    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. || SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA