Insulet Corporation - Omnipod DASH Insulin Management System - Class 2 Recall
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2020 Category: Medical Devices Source Type: alerts
Insulet Corporation - Omnipod DASH Insulin Management System - Class 2 Recall
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Honey Hydrogel - Class 2 Recall
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Honey Hydrogel - Class 2 Recall
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Honey Hydrogel - Class 2 Recall
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Honey Hydrogel - Class 2 Recall
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2020 Category: Medical Devices Source Type: alerts
Abbott Laboratories - ARCHITECT CPeptide Calibrator - Class 3 Recall
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Abbott Laboratories - ARCHITECT CPeptide Reagent - Class 3 Recall
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Dexcom Inc - Dexcom G4 PLATINUM Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts
Dexcom Inc - Dexcom G6 Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts
Dexcom Inc - Dexcom G5 Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts
Insulet Corporation - Omnipod DASH Personal Diabetes Manager (PDM) - Class 2 Recall
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
