Events

Rappel de Device Recall Pericardial Sump

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 California Medical Laboratories 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
    46745
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1176-2008
  • Date de mise en oeuvre de l'événement
    2008-01-24
  • Date de publication de l'événement
    2008-06-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68206
  • 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
    suction pump - Product Code DTS
  • Cause
    Fragment of material: the product may have a loose, stainless steel stringer flash located at the distal tip of the product.
  • Action
    CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.

Device

Device Recall Pericardial Sump
  • Modèle / numéro de série
    Catalog Number SU-20602, Lot Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232 S050233 S050329 S050335NS S050416NS S050538NS S050741 S050759NS S050766NS S050858 S050923NS S050943NS S051041 S051130 S051151 S051175 S051275NS S051318NS S051356NS S051402NS S051490 S051511 S051560NS S051582NS S051596NS S051677ES S051844NS S051881 S051906ES S051925 S052007NS S052142NS S052193NS S052295 S052338NS S060045 S060092NS S060202 S060285 S060401NS S060402NS S060454NS  Lot No. S060492NS S060683NS S060965NS S061010NS S061226 S061434 S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS S062055NS S062132 S070135NS S070252NS S070324 S070482NS S070501NS S070633 S070820NS S070870NS S070882 S070998 S071002NS S071456NS S071457NS S071458 S071459NS S071460NS S071534 S071606 S071607 S071688 S071731NS S071766 S071989 S072100NS S072121NS, and  S072133NS
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
  • Description du dispositif
    CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
  • Manufacturer
    California Medical Laboratories Inc

Manufacturer

California Medical Laboratories Inc
  • Adresse du fabricant
    California Medical Laboratories Inc, 1570 Sunland Ln, Costa Mesa CA 92626-1515
  • Source
    USFDA