279 results
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19ms
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Sources: EU EUDAMED, US FDA
EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Epidural anesthesia kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·March 7, 2018
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014
Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.
FDA Recall
Terminated
·KCI USA, Inc.·Product code OMP·November 4, 2009
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
FDA Recall
Terminated
·KCI USA, INC.·Product code GFD·November 19, 2014
500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
FDA Recall
Terminated
·KCI USA, Inc.·Product code JCX·July 29, 2008
500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
FDA Recall
Terminated
·KCI USA, Inc.·Product code JCX·July 29, 2008
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IOQ·November 4, 2009
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKZ·February 18, 2011
Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
FDA Recall
Terminated
·KCI USA, Inc.·Product code FSA·April 6, 2012