Medtronic Inc. - Contour Plus Link 2.4 - Class 2 Recall
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for quantitative glucose measurement in fresh capillary full blood removed from the user's fingertips or palms. It is only for in vitro diagnostic use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Chemistry Products Cl Slides - Class 3 Recall
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2018 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Chemistry Products Cl Slides - Class 3 Recall
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage: (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2018 Category: Medical Devices Source Type: alerts
Tosoh Bioscience Inc - G8 Automated HPLC Analyzer - Class 2 Recall
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 12, 2018 Category: Medical Devices Source Type: alerts
Clarity Diagnostics Llc - Clarity Urocheck 10SG Urinalysis Strips - Class 3 Recall
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following are...
Source: Medical Device Recalls - July 25, 2018 Category: Medical Devices Source Type: alerts
Cardinal Health 200, LLC - Presource PBDS, Kit, No Spiro Diabetes. - Class 2 Recall
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by t...
Source: Medical Device Recalls - July 19, 2018 Category: Medical Devices Source Type: alerts
Cardinal Health 200, LLC - Presource PBDS, Kit, Common Diabetes - Class 2 Recall
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the...
Source: Medical Device Recalls - July 19, 2018 Category: Medical Devices Source Type: alerts
Tandem Diabetes Care Inc - t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM - Class 2 Recall
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 19, 2018 Category: Medical Devices Source Type: alerts
Anika Therapeutics, Inc. - Hyalomatrix - Class 2 Recall
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the manage...
Source: Medical Device Recalls - July 12, 2018 Category: Medical Devices Source Type: alerts
TUKOL FOR DIABETICS (Dextromethorphan Hbr And Guaifenesin) Liquid [Genomma Lab USA Inc]
Updated Date: Jun 19, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 19, 2018 Category: Drugs & Pharmacology Source Type: alerts
Tosoh Bioscience Inc - STAIA PACK IRIInsulin - Class 2 Recall
ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts
Tosoh Bioscience Inc - STAIA PACK CPeptide - Class 2 Recall
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts
Tosoh Bioscience Inc - STAIA PACK CPeptide II - Class 2 Recall
ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts
Tosoh Bioscience Inc - Tosoh ST AIAPACK HbA1c - Class 2 Recall
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
Integra LifeSciences Corp. - TITAN - Class 2 Recall
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System. Each kit contains 1 of each size. The kit components are packaged in individual corrugated cardboard boxes. Kits are then packaged as a case pack in cardboard boxes. This product is used for off-loading diabetic foot ulcer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 21, 2018 Category: Medical Devices Source Type: alerts
