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 product withdrawal action by Wright Medical. The users concerned received the attached mail (15/12/2016) (292 KB). This safety action is registered at ANSM under the number R1613559.
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 action carried out by GROUPE LEPINE. The users concerned have received the attached letter (12/12/2016) (153 KB). This safety action is registered at ANSM under the number R1613677.
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 product withdrawal action carried out by PROCESS FOR PRF. The users concerned have received the attached mail (06/12/2016) (500 KB). This safety action is registered at ANSM under the number R1613679.
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 carried out by the company SPENGLER. The users concerned have received the attached mail (07/12/2016) (486 KB). This safety action is registered with the ANSM under the number R1613912
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 the withdrawal of a lot made by SIEMENS. The users concerned have received the attached mail (09/12/2016) (172 KB). This safety action is registered with the ANSM under the number R1613974.
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
Stylet, tracheal tube - Product Code BSR
Causa
Vital signs colorado (dba carefusion) is recalling vital signs lightwand stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Acción
Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).
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 the withdrawal of a batch made by the Siemens company. The users concerned have received the attached mail (14/12/2016) (130 KB). This safety action is registered at ANSM under the number R1613977.
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 lot withdrawal action carried out by CERAVER. The users concerned have received the attached mail (27/12/2016) (224 KB). This safety action is registered at ANSM under the number R1614011.
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 lot withdrawal made by Life Partners Europe. The users concerned have received the attached letter. (09/12/2016) (180 KB) This security action is registered with the ANSM under the number R1614178.
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 safety action carried out by ORTHO-CLINICAL DIAGNOSTICS. The users concerned have received the attached mail (15/12/2016) (92 KB). This safety action is registered at ANSM under the number R1614206.
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 the withdrawal of a batch made by the company ORGENTEC. The users concerned have received the attached mail (15/12/2016) (21 KB). This safety action is registered at ANSM under the number R1614209.
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
Ventilator, continuous, facility use - Product Code CBK
Causa
Reports of inaccurate low flow readings. monitored inspiratory tidal volume (vti) and expiratory tidal volume (vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.
Acción
Spacelabs started mailing the Urgent Medical Device Correction- Pediatric Flow Sensor kit, PN: 376-0561-00 used with Spacelabs 700 and 900 series ventilators letter, dated 17 March 2015, via priority service to all US customers.
Spacelabs will be emailing the customer letter (translated as necessary) to all international subsidiaries and distributors of record on March 20, 2015.
Customers are asked to dispose of all pediatric flow sensors purchased from Spacelabs (even if they shipped outside of the time frame in which affected product shipped).
Customers are requested to complete and return the Business Reply Form to Spacelabs Healthcare either by fax to Global Tech Support at 425-363-5758
or scan the form and email to techsupport@spacelabs.com
Spacelabs will send you at no charge replacement pediatric flow sensors (376-0561-01) for all Spacelabs pediatric flow sensors you purchased. These NEW sensors will be marked with a "-01" molded into the body so you can tell the difference between the old sensors and the new ones.
For additional information or technical assistance, please contact:
Technical Support
Spacelabs Healthcare, Inc.
35301 SE Center Street
Snoqualmie, WA 98065
1-800-522-7025 and select 2 for Technical Support
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 lot withdrawal carried out by PerkinElmer. The users concerned have received the attached mail (15/12/2016) (134 KB). This safety action is registered at ANSM under the number R1614212.
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 batch removal action carried out by ABS Bolton Medical. The users concerned received the attached mail (30/03/2017) (205 KB). This safety action is registered at ANSM under the number R1614273.
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 batch withdrawal carried out by Nephrotek. The users concerned received the attached mail (17/01/2017) (428 KB). This safety action is registered at ANSM under the number R1614409.
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 batch removal action carried out by In2Bones. The users concerned have received the attached mail (23/12/2016) (207 KB). This safety action is registered at ANSM under the number R1614440.
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 product quarantine carried out by ETHICAL MEDICAL IMPLANTS (EMI). The users concerned have received the attached mail (15/12/2016) (238 KB). This safety action is registered at ANSM under the number R1614496.
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
Orthopedic tray - Product Code OJH
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 product withdrawal action carried out by DEPUY SYNTHES. The users concerned have received the attached mail (06/01/2017) (356 KB). This safety action is registered with the ANSM under the number R1614567, R1614946.
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 lot withdrawal by Spectranetics Corporation. The affected users have received the attached mail (22/12/2016) (68 KB). This safety action is registered at ANSM under the number R1614597.
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 the single batch recall by Boston Scientific Corporation. The only user establishment concerned in France received the attached mail (26/12/2016) (37 KB). The ANSM has also been informed by the company Boston of the distribution, as a precaution, of safety information intended for users of non-recalled batches (26/12/2016) (127 ko) but manufactured during the same period. This safety action is registered at ANSM under the number R1614784.
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 lot withdrawal carried out by Ortho Clinical Diagnostic France. The affected users have received the attached mail (30/12/2016) (237 KB). This safety action is registered at ANSM under the number R1614816.
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 withdrawal of batches made by COVIDIEN. The users concerned received the attached mail (28/12/2016) (162 KB) and a form to fill out (28/12/2016) (71 KB). This safety action is registered at ANSM under the number R1614947.
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 carried out by B Braun Melsungen AG. The users concerned have received the attached letter (29/12/2016) (1807 ko). This safety action is registered with the ANSM under the number R1615055.
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 the withdrawal of a lot made by the company SIEMENS .. The users concerned have received the attached mail (04/01/2017) (149 KB). This safety action is registered with the ANSM under the number R1615057.