Events

Rappel de Device Recall Reserve, Cassette, CADD, 50ml, mdl 2050P, 21700124

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 MD, 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
    38306
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1214-2007
  • Date de mise en oeuvre de l'événement
    2007-06-18
  • Date de publication de l'événement
    2007-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53378
  • 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
    Medication Cassette Reservoir - Product Code FPA
  • Cause
    Smith medical has become aware that an increase in ph may occur with some medications when instilled in the affected cassettes. also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering flolan.
  • Action
    All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.

Device

Device Recall Reserve, Cassette, CADD, 50ml, mdl 2050P, 21700124
  • Modèle / numéro de série
    102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16, 194X16, 202X16, 205X16, 226X16
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.
  • Description du dispositif
    Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC || 4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Adresse du fabricant
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA