Nidek Inc - MC500 Multicolor Laser Photocoagulator - Class 2 Recall
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2015 Category: Medical Equipment Source Type: alerts
Animas Corporation - Animas Vibe Insulin Infusion Pump - Class 2 Recall
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 31, 2015 Category: Medical Equipment Source Type: alerts
Unistrip Technologies LLC - UniStrip1 - Class 2 Recall
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens Healthcare Diagnostics Dimension Vista HbA1c Flex reagent cartridge and HB1C Flex reagent - Class 2 Recall
Siemens Dimension¿ HB1C Flex¿ reagent cartridge; Dimension¿ Hemoglobin A1c (HB1C) Flex¿ reagent cartridge on the Dimension¿ clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2014 Category: Medical Equipment Source Type: alerts
Roche Diagnostics Operations, Inc. - Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system) - Class 2 Recall
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as pre...
Source: Medical Device Recalls - October 30, 2014 Category: Medical Equipment Source Type: alerts
Animas Corporation - Animas Vibe Insulin Infusion Pump - Class 2 Recall
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 25, 2014 Category: Medical Equipment Source Type: alerts
Animas Corporation - Animas Vibe Insulin Infusion Pump and System - Class 2 Recall
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 25, 2014 Category: Medical Equipment Source Type: alerts
Coloplast Manufacturing US, LLC - Biatain Super NonAdhesive - Class 3 Recall
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 25, 2014 Category: Medical Equipment Source Type: alerts
Lumenis, Inc. - Class 2 Recall
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovasculariza...
Source: Medical Device Recalls - October 1, 2014 Category: Medical Equipment Source Type: alerts
Medtronic MiniMed Inc. - Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System - Class 2 Recall
Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2014 Category: Medical Equipment Source Type: alerts
TRUEPLUS DIABETICS INTENSIVE MOISTURIZING Cream [Nipro Diagnostics, Inc.]
Updated Date: Aug 6, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - August 6, 2014 Category: Drugs & Pharmacology Source Type: alerts
TRUEPLUS DIABETICS FOOT CARE (Allantoin And Dimethicone) Cream [Nipro Diagnostics, Inc.]
Updated Date: Aug 5, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - August 5, 2014 Category: Drugs & Pharmacology Source Type: alerts
Nidek Inc - MC500 Multicolor Laser Photocoagulator - Class 2 Recall
MC 500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Fremont, CA: Manufactured by NIDEK CO., Ltd, 34 14 Maehama, Hiroishi cho, Gamagori, Aichi 4430038, Japan. The Nidek Multicolor Laser Photocoagulator Model MC 500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2014 Category: Medical Equipment Source Type: alerts
DIABETIC SUPPLY OF SUNCOAST, INC. - Advocate RediCode BMBBA006A Blood Glucose Test Strips - Class 1 Recall
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 23, 2014 Category: Medical Equipment Source Type: alerts
TRUEPLUS DIABETICS FOOT CARE Cream [Nipro Diagnostics, Inc.]
Updated Date: Jun 23, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - June 23, 2014 Category: Drugs & Pharmacology Source Type: alerts
