45 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
FDA Recall
Terminated
·CaridianBCT, Inc.·Product code LKN·October 26, 2011
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Recall
Terminated
·Fenwal Inc·Product code LKN·February 25, 2021
Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
FDA Recall
Terminated
·Caridian BCT, Incorporated·Product code LKN·December 9, 2010
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
FDA Recall
Terminated
·Fenwal Inc·Product code LKN·May 24, 2013
Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code LKN·October 18, 2010
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
FDA Recall
Terminated
·CaridianBCT, Inc.·Product code LKN·May 4, 2012
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
FDA Recall
Terminated
·Caridian BCT, Incorporated·Product code LKN·September 21, 2011
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code LKN·April 19, 2011
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
FDA Recall
Terminated
·Gambro BCT, Inc.·Product code LKN·September 18, 2007
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Recall
Terminated
·Fenwal Inc·Product code LKN·February 25, 2021
Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes.
FDA Recall
Terminated
·Irvine Scientific Sales Co Inc·Product code MQE·October 23, 2008
ADVANTX LCN+
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 4, 2017
Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
FDA Recall
Terminated
·Diasorin Inc.·Product code LIP·March 16, 2005
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
FDA Enforcement
Class III
·Terminated·GE Healthcare, LLC·July 3, 2019
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·February 17, 2016
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code DSA·May 10, 2019
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
FDA Recall
Terminated
·Lin-Zhi International Inc·Product code DJG·February 18, 2014
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
FDA Recall
Terminated
·Lin-Zhi International Inc·Product code DIC·January 11, 2019