263 results
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Sources: EU EUDAMED, US FDA
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MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·May 17, 2010
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·June 27, 2012
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 10, 2011
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006
Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 6, 2005
Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2003
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·April 1, 2004
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004
Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004
Jostra HL-20 Heart Lung Machine - guiding pins
FDA Recall
Terminated
·MAQUET Inc.·Product code DTQ·October 3, 2006
DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTQ·August 8, 2007
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·May 3, 2011