Events

Recall of Tubing packs CEC

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by TERUMO.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2008-06-26
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-tubing-packs-preconnectes-cec-societes-terumo-et-hmt
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    On 20/06/2008, the companies Terumo and HMT withdrew from the market the batches specified below of medical devices called: Tubing packs Preconnected, manufactured by Terumo or HMT and distributed by Terumo France, following claims describing the failure to "de-bubble" the arterial filters contained in these CEC packs. CEC Terum packs. References: 2CX-FR078, 2CX-FR073 Batches: 0804057, 0805034. CEC HM packs. References: 8CX + TP7002, 8CX + TP7014, 8CX + TP7029, 8CX + TP704. Lots: 1080409-001, 1080409-002, 1080409-003, 108401-001 and 1080326-001. The companies Terumo and HMT directly notified the recipients of the incriminated lots with the message attached (20/06/2008) (42 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Tubing packs CEC
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    TERUMO

Manufacturer

TERUMO