Events

Rappel de Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer

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 B. Braun Medical, 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
    68040
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1666-2014
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • Date de publication de l'événement
    2014-05-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126847
  • 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
    Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Cause
    B.Braun medical, inc. (bbmi) has received reports of 24 gauge sprotte needles that are missing the accompanying introducer needles.
  • Action
    B/Braun sent an Urgent Medical Device Recall Notification letter dated April 3, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Device Recall Notification in its entirety and ensure that all users in their organization and other concerned persons are informed about this voluntary product recall. The letter should also be forwarded to their customers. Customers were instructed to determine their current inventory of the affected lots within their facility, DO NOT DESTROY ANY AFFECTED PRODUCT. Further use of the affected product should be discontinued immediately and quarantined. Customers should use the attached Product Removal Acknowledgement form to record the total number of inidividual units. If cusotmers have no remaining inventory they should check the box indicating zero inventory. Return the completed Product Removal Acknowledgement form to BBMI Quality Assurance department by fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within 2 weeks of receipt, even if the inventory is zero (0). If customers have any affected product they should call BBMI Customer Support Department at 800-227-2862 to arrange for return and replacement product. Customers with questions were instructed to call the Clinical and Technical Support Department at 1-800-854-6851. For questions regarding this recall call 610-596-2870.

Device

Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer
  • Modèle / numéro de série
    catalog no. 333740, lot no. 61358613, exp. 4/30/2015: Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25%
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to Canada.
  • Description du dispositif
    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer || Spinal injection of anesthetics to provide regional anesthesia
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA