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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the company Oxoid, informed the 02/12/08, the users of the reagent Staphaurex of a withdrawal of batch for lack of performance. The users of this device concerned by this defect in France have received the attached mail (05/12/2008) (20 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
Notes supplémentaires dans les données
Action
Afssaps was informed of a withdrawal of lots of horse serum made by Oxoid on 24/07/08 following bacterial contamination. The users of this device concerned by this defect in France have received the following letter (24/07/2008) (19 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
Notes supplémentaires dans les données
Action
In agreement with AFSSAPS, the OXOID company informed the users of the E. coli-Latex test reagent on 05/06/2008 about the withdrawal of a lot for visible quality defects. The users of this device concerned by this defect, in France, received the attached mail (05/06/2008) (18 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the company OXOID, informed the 27/06/2008, the users of the reagent DR0680M IM used for the detection of heterophile antibodies associated with infectious mononucleosis, the withdrawal of several batches. The users of this device concerned by this defect, in France, have received the attached mail (01/07/2008) (18 ko). This information is intended for laboratory managers, health facility managers and local reactovigilance correspondents for dissemination to the relevant biology departments.
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.
Notes supplémentaires dans les données
Action
In agreement with the Afssaps, the company Oxoïd, informed the 29/10/08, the users of agars Columbia sheep blood, ANC and CAP of the reduction of expiry and the withdrawal of several lots .. The users of this affected by this defect, in France, have received the enclosed letter (31/10/2008) (24 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
Notes supplémentaires dans les données
Action
In agreement with the AFSSAPS, the company Oxoid, informed the 30/05/08, the users of the disks for antibiogram Amoxicilline + clavulanic acid of the recall of a batch .. The users of this device concerned by this defect, in France, have received the following letter (30/05/2008) (13 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
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.
Notes supplémentaires dans les données
Action
The company THERADIAG has informed users of the reagent Optigen Food 30 kit withdrawal of a lot. The users concerned, in France, have received the attached mail (17/01/2013) (173 KB). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance for diffusion to the concerned services.
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.
Notes supplémentaires dans les données
Action
The company COOPER SURGICAL, informed, on 31.10.2012, the users of the uterine manipulator handle Rumi Arch UMH700 and Advincula Arch UMH750 of a batch recall. The users concerned in France have received the following letter (06/12/2012) (196 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 25/11/2011 of the implementation of a security action carried out by the company Origio. The users concerned have received the attached mail (09/12/2011) (100 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by Vascutek. The health professionals and implanting centers concerned received the attached letter (28/11/2013) (117 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by TERUMO. The users concerned have received the attached mail (27/03/2013) (127 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by TERUMO. The affected users will have received the enclosed mail (27/09/2013) (130 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by Terumo BCT. The users concerned received the attached mail (19/11/2013) (86 KB).
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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 13/03/2012 of the implementation of a batch recall carried out by Terumo. The users concerned have received the attached mail (21/03/2012) (250 KB).
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.
Notes supplémentaires dans les données
Action
The Afssaps was informed on 11/10/11 of the implementation of a batch recall carried out by the company Terumo .. The users concerned have received the attached mail (19/10/2011) (183 KB ).
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.
Notes supplémentaires dans les données
Action
The Afssaps was informed on 05/07/2010 of the implementation of a security action carried out by the company Terumo. The users concerned have received the attached mail (09/07/2010) (49 KB).
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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 22/07/2010 of the implementation of a recall carried out by Caridian BCT. The users concerned have received the attached mail (28/07/2010) (401 KB).
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.
Notes supplémentaires dans les données
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.
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.
Notes supplémentaires dans les données
Action
On 28/10/2008, the company TERUMO France withdrew from the market the lots and references mentioned in the recall of the medical device called: Pediatric arterial cannula TenderFlowTM, manufactured by Terumo Cardiovascular Systems, following complaints mentioning a problem of dimensional compatibility between the introducer and the body of the cannula .. The company TERUMO France has directly notified the recipients of the incriminated lots with the message attached (30/10/2008) (144 KB) validated by the 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.
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by Teleflex. The users and distributors concerned received the attached mail (20/01/2015) (514 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a lot withdrawal carried out by TELEFLEX MEDICAL. The users concerned received the attached mail (18/06/2015) (158 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by LMA / TELEFLEX. The affected users and distributors have received the attached mail. (11/02/2015) (252 KB)
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by Teleflex Medical. The users and distributors concerned received the attached mail (21/03/2014) (170 KB).
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a new extension of a recall made by TELEFLEX MEDICAL. The users concerned received the attached mail (27/05/2014) (381 KB). Read too. Probe for compression of esophageal varices Sengstaken, Linton-Nachlas, Bypass subcutaneous ureteral system and endoguides - Teleflex medical - Recall lo. (3/26/2014)
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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by TELEFLEX MEDICAL. The affected users received the attached mail (31/03/2014) (153 KB).