Ortho-Clinical Diagnostics - Class 2 Recall
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts

Ortho-Clinical Diagnostics - Class 2 Recall
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics Inc - Stratus CS Acute Care Troponin I (cTnI) TestPak - Class 2 Recall
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - ADVIA Chemistry Creatine Kinase (CK_L) - Class 2 Recall
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Atellica CH Creatine Kinase (CK_L) - Class 2 Recall
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts

Kingsway Trading Inc. Recalls “ Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement ” because it Contains Banned Ephedra Alkaloids
Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “ Well Balance Xanthium& Siler Combo (Bi Yan Pian) ” Batch No. 130401& Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent. (So...
Source: FDA Food Safety - February 8, 2017 Category: Food Science Source Type: alerts

Siemens Healthcare Diagnostics, Inc - ADVIA Centaur TnIUltra - Class 2 Recall
ADVIA Centaur¿ Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events re...
Source: Medical Device Recalls - July 24, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Model 5392 DualChamber Temporary External Pulse Generator - Class 2 Recall
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary ...
Source: Medical Device Recalls - April 1, 2015 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE/IMMULITE 1000 Turbo Troponin I - Class 2 Recall
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts

Abbott Point of Care Canada Limited - Abbott Point of Care iStat cTnI cartridge - Class 2 Recall
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts