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.
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The Afssaps was informed on 06/07/2011 of the implementation of a recall made by the company Dedienne Sante. The three users concerned received the attached mail (18/07/2011) (12 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.
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The ANSM has been informed of the implementation of the recall of a batch carried out by Dedienne Santé. The users concerned have received the attached letter (02/05/2014) (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.
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On March 6, 2008, the company FH ORTHOPEDICS removed from the market the batches of the references specified in the appendix (06/03/2008) (13 KB) of the medical devices called "glénosphère, glena base, handle of the range prostheses d 'shoulder ARROW', manufactured by IMPLANTS INDUSTRIE following the finding of a difficulty of adaptation with instruments and implants manufactured currently by FH Industrie. The company FH ORTHOPEDICS has directly notified the recipients of the incriminated lots with the enclosed message (06/03/2008) (14 ko) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned will be informed by Afssaps.
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.
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In agreement with Afssaps, the company FH Orthopedics, informed, on 10/12/08, the users of the batch recall of the ATLAS hip prosthesis cores. The users concerned, in France, received the attached mail. (16/12/2008) (25 ko) .. 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.
Extra notes in the data
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On 29/01/09 the company FH ORTHOPEDICS removed from the market the lots mentioned in the appendix of the medical device called INSERT PE TRIANON, manufactured by FH Industrie following a labeling error on the second packaging of this device on which it is mentioned ' 'Sterile' when it is not, only the bag in contact with the implant must be marked '' Sterile '' .. The company FH ORTHOPEDICS has directly notified the recipients of the incriminated lots using the attached message (29/01/2009) (17 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 competent European authorities concerned are informed of this measured 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.
Extra notes in the data
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The ANSM has been informed of the implementation of a gradual withdrawal of lots with recommendations made by the company FRESENIUS MEDICAL CARE .. The users concerned have received the attached mail (14/12/2016) (69 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.
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The company FRESENIUS MEDICAL CARE wishes to make an amendment to the urgent security information released on December 9, 2016. The users concerned have received the attached mail (02/01/2017) (30 KB). Read too. Peritoneal dialysis line - Sleep.safe Plus, Sleep.safe Paed - Fresenius Medical Care - Lot recall (14/12/2016) (69 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.
Extra notes in the data
Action
The Afssaps was informed on 17/08/11 of the implementation of a recall of batches made by the company Fresenius Kabi .. The users concerned received the attached mail (23/08/2011) (387 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.
Extra notes in the data
Action
ANSM has been informed of the implementation of a recall made by FRESENIUS KABI. The users concerned received the attached mail (16/12/2013) (23 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.
Extra notes in the data
Action
Afssaps has been informed of the implementation of a batch recall carried out by Hélix Médical. The affected users received the attached mail (22/07/2011) (163 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.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a batch withdrawal carried out by the company PULSION MEDICAL SYSTEMS SE .. The users concerned have received the attached mail (03/08/2015) (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.
Extra notes in the data
Action
Information for local correspondents of materiovigilance, directors of health facilities, surgery and pharmacy. ANSM has decided to suspend the placing on the market, commissioning, importing, exporting and distributing of these products until they are brought into compliance, as well as stopping the use and withdrawing them. Re-usable surgical instruments from the Titanox range marketed by GEM Universal Industrie. For these medical devices, the company does not have a CE marking file compliant. The users concerned have received the attached mail (05/02/2014) (33 KB). Read auss. Surgical instruments put on the market by the company GEM Universal Industrie: Withdrawal and suspension of placing on the market - Information point (05/02/2014) (0 ko) Animal health decision of 28/01/2014 suspending placing on the market, putting into service, importing, exporting, distributing and using surgical instruments, sterilizers and tensiometers placed on the market by GEM Universal Industries, as well as the withdrawal of these products (05/02/2014) (355 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.
Extra notes in the data
Action
In agreement with Afssaps, the company GE Healthcare, informed, on December 7, 2009, the users of resuscitation circuits T for Giraffe and Panda GE Healthcare resuscitation tables the withdrawal of certain batches of these circuits. The users concerned, in France, have received the attached letter (11/12/2009) (665 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.
Extra notes in the data
Action
Afssaps was informed on 15/09/2010 of the implementation of a recall carried out by GE Medical Systems SCS. The users concerned have received the attached mail (30/09/2010) (188 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.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a lot withdrawal carried out by the company GE HEALTHCARE FINLAND OY .. The users concerned have received the attached mail (02/07/2015) (185 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.
Extra notes in the data
Action
ANSM has been informed of the implementation of a safety action carried out by GE Healthcare. The affected users have received the attached mail (05/12/2016) (358 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.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch withdrawal by GE Healthcare. The users concerned have received the attached letter. (09/08/2018) (163 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.
Extra notes in the data
Action
Afssaps has been informed of the implementation of a recall made by Geomed. The users concerned received the attached mail (16/01/2012) (7290 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.
Extra notes in the data
Action
Afssaps was informed on December 19, 2008 of a batch recall of the QUADROX-I oxygenators with integrated arterial filter carried out by the MAQUET company on December 19 following a leakage case at the purge valve of the integrated arterial filter. The users concerned, in France, have received the attached mail (30/12/2008) (149 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.
Extra notes in the data
Action
The Afssaps was informed on 11/10/2010 of the implementation of a recall carried out by the company MAQUET. The users concerned have received the attached mail (29/10/2010) (95 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.
Extra notes in the data
Action
The Afssaps was informed on 01/09/2010 of the implementation of a recall made by the company Maquet. The users concerned have received the attached mail (07/09/2010) (74 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.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a recall made by the company I2A .. The users concerned have received the attached mail (27/02/2014) (23 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.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a security action carried out by the company Datascope .. The users concerned have received the attached mail. (09/05/2012) (1077 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.
Extra notes in the data
Action
Afssaps has been informed of the implementation of a batch recall carried out by the company Maquet. The affected users received the attached mail (12/01/2012) (143 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.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch recall carried out by the company Maquet. The users concerned have received the attached mail (18/05/2012) (54 KB).