82 results
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Sources: EU EUDAMED, US FDA
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Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
FDA Recall
Terminated
·Arizant Inc·Product code DWJ·December 17, 2009
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·October 3, 2008
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids.
FDA Recall
Terminated
·Arizant Inc·Product code DWJ·December 17, 2009
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245. Intended to warm blood, blood products and liquids.
FDA Recall
Terminated
·Arizant Inc·Product code DWJ·December 17, 2009
Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. To provide power to pressure infusers.
FDA Recall
Terminated
·Arizant Inc·Product code DWJ·December 17, 2009
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Recall
Terminated
·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 25, 2011
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 12, 2014
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
FDA Enforcement
Class II
·Terminated·Paa Laboratories Inc·July 24, 2013
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007