327 results
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13ms
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Sources: EU EUDAMED, US FDA
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ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 14, 2011
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
FDA Enforcement
Class II
·Terminated·Microgenics Corporation·December 10, 2014
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.
FDA Enforcement
Class II
·Terminated·GE Healthcare·June 3, 2015
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.
FDA Recall
Terminated
·GE Healthcare·Product code CCL·April 24, 2015
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·October 20, 2014
Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
FDA Recall
Terminated
·Hospira Inc·Product code FRN·December 3, 2008
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
FDA Recall
Terminated
·Teleflex Medical·Product code CAI·July 9, 2014
Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
FDA Recall
Terminated
·MMS Sales Corp·Product code CAI·February 21, 2005
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF470-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF375-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DSNCF070-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # F90736. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF370-6127Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF475V-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # F90698. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # F90768. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF375-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF470-6113. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF477S-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAI·August 1, 2008