31 results
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Sources: EU EUDAMED, US FDA
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Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·March 24, 2006
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.
FDA Recall
Terminated
·Gibson Laboratories Inc·Product code JSO·December 17, 2009
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 11, 2017
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·September 30, 2015
LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·December 25, 2019
Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KEY·October 30, 2007
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KEY·September 6, 2007
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
FDA Recall
Terminated
·Physio-Control, Inc.·Product code MKJ·January 27, 2016
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
FDA Recall
Terminated
·Radiometer America Inc·Product code JJS·September 7, 2017
LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code PRL·February 18, 2019
Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code CBR·October 8, 2007
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DPT·August 26, 2015
Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.
FDA Recall
Terminated
·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005