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 August 10, 2005, Beckman Coulter withdrew the batch T502014 (expiry 28/02/2007) of the in vitro diagnostic medical device called SYNCHRON® Systems Reactive Wash Concentrate II - reference 450160. This device is a detergent dedicated to Synchron CX controllers.This recall is made because some cans may leak when placed in the PLC and subjected to the pressure of 5 PSI. The company Beckman Coulter has directly notified the recipients of the offending lot by means of the attached message (10/08/2005) (23 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, 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
Following the animal health decision of 04 July 2011 (01/01/1970) (0 KB), Choc Medical, Sun Communication, Philoderm Aesthetics and Aesthetics Dermal are required to withdraw from the market all lots of medical devices called Hyalskin , Mesoface, Reparestim, Biostyle, Rofilan Hylan Gel, Philoderm Beauty Gel, Zetaderm, Zetavisc, Esthirase, Philoderm, Professional, Mesoface, Repairs, Refills and Stimulates. Indeed, the manufacture, placing on the market, the distribution, the export and the use of these products were suspended by decision of the Director General of Afssaps of July 04, 2011, until the products to the regulations applicable to them. The companies have directly notified the recipients of the offending lots. The competent European authorities concerned are informed of this measure by Afssaps. Given the small number of recipients, they are notified directly by the laboratories. No alert number has been assigned to these withdrawals. Read auss. Hyalskin, Mesoface, Reparestim HA, Biostyle, Zetaderm, Zetavisc, Philoderm Professionnal Mesoface - Medical Shock, Sun Communication, Philoderm Aesthetics - Product Withdrawal. (18/10/2011) Decision of 03 October 2011 withdrawing and suspending the manufacture, placing on the market, distribution, export and use of wrinkle treatment and filling products, skin depressions and restoration volumes manufactured by the company CHOC MEDICAL and marketed by the company CHOC MEDICAL under the brands Hyalskin®, Mesoface® and Reparestim HA®, by the company SUN COMMUNICATION under the brand Biostyle®, by the PHILODERM AESTHETICS under the trademarks Zetaderm®, Zetavisc® and Mesoface Philoderm Professional®, and repealing the decision of 04 July 2011
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 December 15, 2004, Beckman Coulter withdrew lot T407145 (expiry 31.10.05) from the in vitro diagnostic medical device called SYNCHRON® Systems Reagent Lactate Dehydrogenase (LD-P) - reference 442660 .. Beckman Coulter Company directly notified the recipients of the offending lot by means of the attached message (15/12/2004) (24 KB). This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, 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
In agreement with Afssaps, the company All-Diag informed, on 04/06/04, the users of Syphilitop + the withdrawal of a lot of this device as a precaution, following the declaration of results falsely The users of this device concerned by this defect, in France, have received the attached mail (04/06/2004) (9 ko). This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for diffusion to the concerned biological 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
In agreement with Afssaps, the company ALL DIAG proceeded, on 08/09/2006, with the recall of a lot of tests SYPHILITOP Optima following the loss of sensitivity of this lot. The users of this device concerned by this defect, in France, received the attached mail (08/09/2006) (27 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.
Notas adicionales en la data
Acción
Asept InMed informed Afssaps on March 26, 2003, that it is recalling all batches of SYRINGE-SYRINGE FITTINGS, reference R01, manufactured by EMP. The enclosed mail (27/03/2003) (8 KB) was sent to the 70 user centers to warn them of the recall of these products, only marketed in France.
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 Dade Behring proceeded, on 27/12/06, to the recall of 3 batches of the reagent Syva Emit 2000 Phenobarbital due to a lack of stability. The users of this device concerned by this defect, in France, received the attached mail (29/12/2006) (9 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.
Notas adicionales en la data
Acción
In agreement with Afssaps, TYCO Healthcare on 11/05/2004 recalled several batches of TA surgical staplers due to a quality defect. The health facilities concerned by the recall in France received the following letter (11/05/2004) (445 ko) to the attention of the local correspondents of materiovigilance, for dissemination to the surgical services. The other European Competent Authorities have been informed of this measure by the manufacturer. List of surgical staplers concerned (11/05/2004) (108 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
Afssaps was informed on February 4, 2005 that the MEDTRONIC company was withdrawing from the market the serial numbers of the references specified in the appendix (04/02/2005) (6 ko), of the medical device called "Talent AAA aortic stents with the system". Xcelerant "following the identification of a number of laying systems with insufficiently welded marker strips, which may lead to detachment of the marker strip. The establishments concerned were notified directly by of the attached message (04/02/2005) (16 KB). The manufacturer will exchange the devices returned later .. The competent European authorities concerned are informed of this measure by the manufacturer .. Serial numbers of the relevant references (04/02/2005) (6 ko Medtronic mail (04 / 02/2005) (16 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 Director General of the French Agency for Health Safety of Health Products. Vu. books II and III of the fifth part of the code of public health and in particular article L. 5312-1. Vu. the Agency's letters of 27 December 1999 and 4 August 2000 requesting MEDTRONIC to provide information on the TALENT LPS Standard Abdominal Range Aortic Endoprosthesis. Vu. the report prepared by Afssaps' aortic stents working group. Vu. the meeting of 30 January 2001 at the French Agency for Health Safety of Health Products at which MEDTRONIC was able to present its observations on the conclusions of the work of the working group "aortic stents". Vu. Afssaps letter of 20 June 2001 to MEDTRONIC informing it of the intention to suspend the placing on the market and use of the TALENT LPS standard abdominal range endoprosthesis for the endovascular treatment of infrarenal abdominal aortic aneurysms. Vu. MEDTRONIC's replies dated July 6 and August 3, 2001. Seen. the meetings of 17 July and 24 September 2001. Recital. the pre-clinical and clinical data provided by the manufacturer do not provide sufficient assurance as to the efficacy and safety of the TALENT LPS stent. Considering. the existence of alternatives for the management of infrarenal abdominal aortic aneurysms. DECID. Article 1.. The marketing and use of the TALENT LPS standard abdominal range endoprosthesis is suspended. Article. . The Director of Medical Devices Evaluation and the Director of Inspection and Establishments are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Done at Paris on 15 October 2001
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 BOSTON SCIENTIFIC company requested, on July 20, 2004, the health establishments concerned to stop using the TAXUS ™ Express2 ™ Monorail® stent systems and the Express2 ™ Monorail® coronary stent systems on hold a reminder notification of these devices comprising the precise list of the batches concerned, following several cases of non-deflation of the balloon during the stent placement. All health facilities were recipients of the enclosed alert form (21/07/2004) (86 KB). The other European Competent Authorities have been informed of this measure by the manufacturer. Any incident or any risk of serious incident on these devices must be declared within the framework of materiovigilance to the French Agency for the safety of health products - Department of Vigilance - Fax: 01 55 87 37 0. This information concerns Directors of health establishments, local correspondents of materiovigilance and pharmacists of health establishments using these devices for dissemination 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
On December 10, 2007, the company PLUS ORTHOPEDICS removed from the market the batches of the references specified in the attached reminder message, of the medical device called "knee implants of the TC-Plus and RT-Plus range", following an error composition of the alloy used to make these implants. The company ORTHOPEDICS France has directly notified the recipients of the incriminated lots with the message attached (13/12/2007) (22 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
In agreement with Afssaps, ABBOTT informed, on 10/04/07, the users of the TDx / TDx FLx Methotrexate II reagent of a withdrawal of batch following the identification of a configuration error of certain kits of a lot. The users of this device concerned by this defect, in France, have received the attached mail. (10/04/2007) (44 KB) The competent European authorities have been 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
In agreement with Afssaps, Abbott, on 09/11/07, informed the users of the TDx Gentamicin reagent that a batch of reagent for stability defect had been removed. The users of this device concerned by this defect, in France, have received the attached mail (14/11/2007) (27 KB). The competent European authorities have been informed of this measure by the manufacturer. addressed to laboratory managers, health facility directors and local correspondents for reactive surveillance for dissemination 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
On August 10, 2005, Inverness Medical France withdrew from the market lot 17597M200 of the in vitro diagnostic medical device called Test Pack Plus hCG Combo reference 3A6016FR following the possibility of obtaining false positive results .. This device is a test immunoassay used for the early detection of pregnancy by qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. In the case of a positive result, this test is confirmed by a quantitative determination in the serum. The company has directly notified the recipients of the offending lot by means of the attached message (10/08/2005) (26 KB) validated by Afssaps. The relevant European authorities concerned are informed by the manufacturer .. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, 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
Afssaps was informed on 15/06/04 of the withdrawal of 8 lots of TestPack Plus Strep A by Orgenics on 14/06/04 following several reports of false positives, for the detection of Streptococcal antigen. group A. The users of this device concerned by this defect in France have received the following letter (21/06/2004) (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.
Notas adicionales en la data
Acción
In agreement with the Afssaps, the company All Diag, informed, on 21/06/2007, the users of the Tetanotop + reagent used for the semi-quantitative determination of anti-tetanus toxin antibodies, the recall of a lot. The users of this device concerned by this defect, in France, have received the attached mail (21/06/2007) (19 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 company Sulzer Cardiovascular SA decided to proceed with the withdrawal of these testers and sent the attached letter (11/07/2002) (166 KB), informing the directors of the establishments and the heads of cardiac surgery 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
In agreement with Afssaps, Prothéos Industries on April 5th, 2004 recalled the first-generation femoral stems THEOS to be cemented and THEOS HAP manufactured between 1998 and January 2000. The attached mail (05/04/2004 ) (238 kb) was sent to the local correspondents of materiovigilance and the directors of the health establishments concerned for distribution to the orthopedic surgeons. The other European countries are not concerned 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
In agreement with Afssaps, the Paul Hartmann laboratories decided to suspend the marketing and to withdraw from the market all batches of the medical device THERMOVAL RAPID, electronic thermometer (ref 925033). Indeed, when used in the vicinity of electrical devices emitting electrostatic fields, the microprocessor of the thermometer may be damaged, which may result in the display of erroneous temperatures (too low temperatures). The 33 pharmacies receiving the batches were informed directly of this recall (see attached letter (19/04/2004) (67 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
Batch No. 505492 of the reagent called: THROMBOREL S-code OUHP435, from the company DADE BEHRING is withdrawn from the market, following an extension of the Quick Time (exploration of the extrinsic pathway of coagulation) with some vials.
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 has been informed of a withdrawal of all batches of the references specified in the attached list (18/06/2004) (187 KB), of metal tibial bases and related inserts Genesis Uni made by the company SMITH and NEPHEW June 18, 2004, due to problems of intraoperative snap-fastening of the inserts on the tibial bases reported in the USA. No postoperative complication has been reported to date. The 12 health facilities concerned by this recall in France were warned directly.
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
PLUS Endoprothetik informed Afssaps on August 05, 2003 that since July 31, 2003, it has been recalling the RT-PLUS and RT-PLUS Modular polyethylene tibial inserts of 17 mm thickness, following the rupture of one of these inserts occurred in Greece in May 2003 .. The references recalled are. 24049, 24059, 24069, 24079 and 24089 (inserts with clamps 24044, 24054, 24064, 24074 and 24084 (inserts without clamps) 71 tibial inserts RT-PLUS and RT-PLUS Modular 17 mm thick were distributed in France some 30 have been implanted, and no other incident concerning these references has been notified to materiovigilance.
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 i2a, informed the 06/09/2007, the users of the disks for antibiogram of Ticarcilline + Clavulanic acid of the recall of several lots. The users of this device concerned by this defect, in France, received the attached mail (10/09/2007) (22 KB). 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 Biorad informed the users of the Ticarcilline + Clavulanic acid discs on 13/09/04 of a decrease in inhibition diameters with three batches. The users of the device concerned by this defect, in France, have received the following letter (16/09/2004) (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.