Events

Rappel de Spinal Anesthesia Trays

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 Smiths Medical ASD, 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
    66351
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0160-2014
  • Date de mise en oeuvre de l'événement
    2013-09-23
  • Date de publication de l'événement
    2013-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122132
  • 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
    Visual particulate in the glass ampules of 5% lidocaine hcl and 7.5% dextrose injection, usp, 2 ml ampoule, ndc # 0409-4712-01, hospira lot number 23-227-dk. these ampules are included in certain portex spinal anaesthesia trays.
  • Action
    Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to spinal@smiths-medical.com. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361. For questions regarding this recall call 800-258-5361.

Device

Spinal Anesthesia Trays
  • Modèle / numéro de série
    Lot: 2445604, 2440523, 2445605, 2445606, 2450812
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.
  • Description du dispositif
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 || The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA