Device Recalls

  • 0 ::
      • Event_date_terminated : 2017-03-03
        • Firm_fei_number : 3008853977
          • Openfda ::
              • Regulation_number : 882.5950
                • Fei_number ::
                    • 0 : 3008853977
                  • Device_name : Device, Neurovascular Embolization
                    • K_number ::
                        • 0 : K113412
                          • 1 : K153658
                        • Device_class : 2
                          • Medical_specialty_description : Neurology
                            • Registration_number ::
                                • 0 : 3008853977
                          • Res_event_number : 74425
                            • Other_submission_description :
                              • K_numbers ::
                                  • 0 : K113412
                                    • 1 : K153658
                                  • Product_res_number : Z-2174-2016
                                    • Product_code : HCG
                                      • Root_cause_description : Process Change Control
                                        • Pma_numbers ::

    Device Recalls

    • 1 ::
        • Event_date_terminated : 2016-12-14
          • Firm_fei_number : 1044713
            • Openfda ::
                • Regulation_number : 866.3235
                  • Fei_number ::
                      • 0 : 1044713
                    • Device_name : Antiserum, Cf, Epstein-Barr Virus
                      • K_number ::
                          • 0 : K981831
                        • Device_class : 1
                          • Medical_specialty_description : Microbiology
                            • Registration_number ::
                                • 0 : 1044713
                          • Res_event_number : 73694
                            • Other_submission_description :
                              • K_numbers ::
                                  • 0 : K981831
                                • Product_res_number : Z-1687-2016
                                  • Product_code : GNP
                                    • Root_cause_description : Unknown/Undetermined by the Firm
                                      • Pma_numbers ::

      Device Recalls

      • 2 ::
          • Event_date_terminated : 2011-12-27
            • Firm_fei_number : 2182269
              • Openfda ::
                  • Regulation_number : 870.1340
                    • Medical_specialty_description : Cardiovascular
                      • Device_name : Introducer, Catheter
                        • Device_class : 2
                      • Res_event_number : 56222
                        • Other_submission_description :
                          • K_numbers ::
                              • 0 : K091137
                                • 1 : K092575
                                  • 2 : K093130
                                • Product_res_number : Z-2179-2010
                                  • Product_code : DYB
                                    • Root_cause_description : Process Design
                                      • Pma_numbers ::

        Device Recalls

        • 3 ::
            • Event_date_terminated : 2017-11-21
              • Firm_fei_number : 3006369484
                • Openfda ::
                    • Regulation_number : 892.1000
                      • Fei_number ::
                          • 0 : 3006369484
                        • Device_name : Coil, Magnetic Resonance, Specialty
                          • K_number ::
                              • 0 : K141832
                            • Device_class : 2
                              • Medical_specialty_description : Radiology
                                • Registration_number ::
                                    • 0 : 3006369484
                              • Res_event_number : 74477
                                • Other_submission_description :
                                  • K_numbers ::
                                      • 0 : K141832
                                    • Product_res_number : Z-2312-2016
                                      • Product_code : MOS
                                        • Root_cause_description : Nonconforming Material/Component
                                          • Pma_numbers ::

          Device Recalls

          • 4 ::
              • Event_date_terminated : 2016-12-12
                • Firm_fei_number : 2936485
                  • Openfda ::
                      • Regulation_number : 888.3040
                        • Fei_number ::
                            • 0 : 2936485
                          • Device_name : Fastener, Fixation, Nondegradable, Soft Tissue
                            • K_number ::
                                • 0 : K131769
                              • Device_class : 2
                                • Medical_specialty_description : Orthopedic
                                  • Registration_number ::
                                      • 0 : 2936485
                                • Res_event_number : 73846
                                  • Other_submission_description :
                                    • K_numbers ::
                                        • 0 : K131769
                                      • Product_res_number : Z-1634-2016
                                        • Product_code : MBI
                                          • Root_cause_description : Device Design
                                            • Pma_numbers ::