Events

Rappel de Device Recall Malleable 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-1177-2008
  • 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=68207
  • 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 Malleable Pericardial Sump
  • Modèle / numéro de série
    Catalog Number SU-20802, Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118 S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS S071463 S071620 S071754 and S071985.
  • 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 Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; 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