Events

Rappel de Device Recall Portex Arterial Blood Sampling Line Draw Syringes

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
    66837
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1186-2014
  • Date de mise en oeuvre de l'événement
    2013-11-22
  • Date de publication de l'événement
    2014-03-12
  • 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=124282
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Cause
    Issue with the plunger tip of the portex¿ arterial blood sampling line draw syringes.
  • Action
    Smiths Medical sent an Urgent Field Safety Notice dated November 22, 2013, to all affected consignees via FedEx beginning on November 23, 2013. Distributors were instructed to notify their customers. Customers were instructed to inspect their inventory for the affected product and quarantine the affected syringes. Complete and return the attached Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to LineDraw@smiths-medical.com. Upon receipt of the completed form, a customer service representative will contact them to arrange for exchange of their unused affecte devices for credit or replacement. Customers were instructed to forward the notice to all personnel who need to be aware within their organization and to any organization where the potentially affected devices have been transferred. Customers were instructed to report any issues with the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions regarding this recall call 603-352-3812.

Device

Device Recall Portex Arterial Blood Sampling Line Draw Syringes
  • Modèle / numéro de série
    2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
  • Description du dispositif
    4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) || Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
  • 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