Events

Rappel de Device Recall MedStream Programmable Infusion Pump

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 Codman & Shurtleff, Inc..

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
    67921
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1571-2014
  • Date de mise en oeuvre de l'événement
    2015-11-10
  • Date de publication de l'événement
    2014-05-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126613
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Cause
    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
  • Action
    Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at Codmanproductcomplaints@dpyus.jnj.com We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to

Device

Device Recall MedStream Programmable Infusion Pump
  • Modèle / numéro de série
    Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH,  NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75,  NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5,  NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N,  NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT,  NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
  • Description du dispositif
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 || The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Adresse du fabricant
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA