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.
Notas adicionales en la data
Acción
Afssaps was informed on 15/11/10 of the implementation of a batch recall carried out by the company Penumbra. The affected users have received the attached mail (13/12/2010) (27 KB). Only one institution is affected by this recall.
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.
Notas adicionales en la data
Acción
Recall of all lots of Flavicheck HCV reagent marketed by Qualpro and distributed by Servibi. In agreement with Afssaps, following the discontinuation of the distribution of Flavicheck HCV reagent carried out on 19/08/08, the company Qualpro, proceeded, on 01/09/08, to the withdrawal of all lots available on the market due to a performance defect. Recommendations issued by Afssaps concerning the retest of negative samples are attached to mail sent to users. The users of this device concerned by this defect in France have received the enclosed mail. The competent European authorities have been informed of this measure by Afssaps. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments. Distribution stop. Recommendation Afssaps (04/09/2008) (23 KB Joint mail (04/09/2008) (27 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.
Notas adicionales en la data
Acción
In agreement with Afssaps, following the cessation of distributio. of the Flavicheck HCV reagent carried out on 19/08/08, the company Qualpro, proceeded, on 01/09/08, to the withdrawal of all lots available on the market due to a lack of performance. Recommendations issued (04/09/2008) (23 KB) by the Afssaps concerning the retest of negative samples are attached to the mail sent to users. The users of this device concerned by this defect in France have received the following letter (04/09/2008) (27 KB). The competent European authorities have been informed of this measure by Afssaps. 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.
Notas adicionales en la data
Acción
In agreement with the Afssaps, the company Qualpro Diagnostics, informed August 19, 2008, the users of the reagent for detection of antibodies against the hepatitis C virus Flavicheck HCV the discontinuation of distribution of this reagent following the unexpected results observed during a Flavicheck HCV reagent control performed by Afssaps .. The users of this device concerned by this defect, in France, received the attached mail (20/08/2008) (14 KB) .. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for dissemination to the concerned biology departments.
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.
Notas adicionales en la data
Drape, surgical - Product Code KKX
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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.
Notas adicionales en la data
Acción
In agreement with Afssaps, the company Perkin Elmer, informed the 12/06/09, the users of the PAPP-A reagent of a withdrawal of several lots due to a lack of performance leading to an increased value of the calculation of risk. The users of this device concerned by this defect, in France, received the attached mail (15/06/2009) (112 KB). Afssaps has issued additional recommendations (15/06/2009) (23 KB) to the laboratories concerned. 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.
Notas adicionales en la data
Acción
The Agency has been informed of the implementation of a safety action carried out by Perkin Elmer. The users concerned have received the attached mail (21/11/2011) (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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal made by Perkin Elmer. The users concerned have received the attached mail (16/08/2012) (193 KB). This information is addressed to laboratory managers, directors of health establishments and local correspondents of reactive vigilance for diffusion to the services concerned.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of a recall made by Perkin Elmer. The users concerned have received the attached mail (03/10/2014) (777 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.
Notas adicionales en la data
Acción
In agreement with Afssaps, the Perouse laboratory broadcast, on the 13/02/09, a recall mail of several references of chambers to catheter implantable POLYSITE. The users concerned in France have received the attached letter (16/02/2009) (42 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.
Notas adicionales en la data
Acción
On 14/01/2010, the company PEROUSE MEDICAL removed from the market all batches of references of the named medical devices. V60 vein strippers. V90 vein strippers. Versatile vein strippers Polystripp® PST0. This recall is made following a report of breakage distal tip distorted during the procedure. The company PEROUSE MEDICAL has directly notified the recipients of the incriminated lots with the help of the enclosed message 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.
Notas adicionales en la data
Acción
Perouse Medical has informed users of the chest tube of a product withdrawal. The users concerned, in France, received the attached mail (10/10/2012) (111 KB). 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.
Notas adicionales en la data
Acción
The ANSM was informed on 15/05/2012 of the implementation of a recall carried out by the company Perouse Medical .. The users concerned have received the attached mail (23/05/2012) (98 ko) .
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a recall made by the company PEROUSE MEDICAL. The health professionals and centers concerned received the attached letter (03/05/2013) (347 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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a recall made by PEROUSE MEDICAL .. The users / distributors concerned have received the attached mail (12/02/2014) (201 KB).
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.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a recall made by the company Perouse Plastie. The health professionals concerned have received the attached mail (05/12/2012) (304 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.
Notas adicionales en la data
Acción
Erratum to mail sent on 27/02 / 2013ANSM has been informed of the implementation of a recall made by Perouse Plastie. The health professionals concerned have received the enclosed letter which cancels and replaces (08/03/2013) (367 ko the mail sent on 27/02/2013 (details of the lots concerned).
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a recall of two sets of templates pre-filled with silicone gel for breast prostheses, the company Mentor, carried out by the company Perouse Plasty. The health professionals concerned received the attached letter (06/06/2014) (520 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.
Notas adicionales en la data
Acción
On 29/12/2010, the company HOSPIRA withdrew from the market batches 682075H and 740545H (reference 13261) and lot 761915H (reference 13280) of the medical device called "Tubulure pour pompe GemStar Epidurale or NPT" following the setting evidence of an underestimation of the administration when the flow control parameters are defined with a low flow rate (less than 10 ml / h). The company HOSPIRA has directly notified the recipients of the incriminated lots with the message attached (03/01/2011) (34 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.
Notas adicionales en la data
Acción
Afssaps was informed on 12/10/2011 of the implementation of a batch recall carried out by the company Hospira. The users oncernés have received the mail attached (20/10/2011) (30 ko).
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.
Notas adicionales en la data
Heart-Valve, Allograft - Product Code MIE
Causa
The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.
Acción
The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of a product recall carried out by the company Hospira Inc. The users concerned have received the attached mail (21/09/2012) (66 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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Hospira. The users concerned received the attached mail (10/12/2013) (25 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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Hospira. The affected users have received the attached mail (25/11/2013) (21 KB). This information is for CLMV and ES directors.