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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
FDA Recall
Terminated
·Quest Medical, Inc·Product code DTR·July 29, 2010
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
FDA Recall
Terminated
·Quest Medical, Inc.·Product code DTR·December 17, 2019
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
FDA Recall
Terminated
·Quest Medical, Inc.·Product code DTR·October 28, 2015
Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
FDA Recall
Terminated
·Quest Medical, Inc·Product code DWF·May 23, 2003
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
FDA Recall
Terminated
·Quest Medical, Inc.·Product code HNL·February 26, 2015
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
FDA Enforcement
Class II
·Terminated·Quest Medical, Inc.·December 9, 2015
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
FDA Enforcement
Class II
·Terminated·Quest Medical, Inc.·April 8, 2015
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
FDA Enforcement
Class II
·Terminated·Quest Medical, Inc.·June 3, 2020
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
FDA Recall
Terminated
·Oakworks Inc·Product code LGX·June 29, 2021