206 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).
FDA Recall
Terminated
·DiaSorin Molecular LLC·Product code PLO·May 12, 2020
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PLO·September 10, 2018
Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20 M001182840 18-284 11294909 RENEGADE HI FLO 105/10 M001182850 18-285 12703162 RENEGADE HI FLO 105/20 M001182860 18-286 11339895 RENEGADE HI FLO 115/10 M001182870 18-287 12669789 RENEGADE HI FLO 115/20 M001182880 18-288 11295844 RENEGADE HI FLO 135/10 M001182890 18-289 12703088 RENEGADE HI FLO 135/20 M001182900 18-290 11295637 RENEGADE HI FLO 150/10 M001182910 18-291 12684437 RENEGADE HI FLO 150/20 M001182980 18-298 11320970 RENEGADE HI FLO 105/10 KIT M001182990 18-299 12721456 RENEGADE HI FLO 105/20 KIT M001183000 18-300 11319972 RENEGADE HI FLO 115/10 KIT M001183010 18-301 12703082 RENEGADE HI FLO 115/20 KIT M001183020 18-302 11279134 RENEGADE HI FLO 135/10 KIT M001183030 18-303 11296276 RENEGADE HI FLO 135/20 KIT
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KRA·August 26, 2009
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·August 26, 2011
Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA Made in Ireland, Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182570 18257 Renegade" 18 150/10 (2-tip marker) M001182590 18259 Renegade" 18 150/20 (2-tip marker) M003182880US0 182880US Neuro Renegade" Hi Flo" 135/10 M003182890US0 182890US Neuro Renegade" Hi Flo" 135/20 M003182900US0 182900US Neuro Renegade" Hi Flo" 150/10 M003182910US0 182910US Neuro Renegade" Hi Flo" 150/20
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KRA·August 26, 2009
Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006
Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006
Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006
20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
FDA Enforcement
Class II
·Terminated·Repro-Med Systems, Inc.·October 16, 2019
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·March 24, 2011
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 10, 2021
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
FDA Enforcement
Class II
·Terminated·Breg Inc, An Orthofix Company·September 12, 2012
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 10, 2021
Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005
Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
FDA Recall
Terminated
·Arrow International Inc·Product code FPA·February 1, 2010
Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.
FDA Recall
Terminated
·Wolf Medical Supply Inc.·Product code MEB·October 20, 2011