Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - 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
Gentell, Inc - Gentell Hydrogel Ag - Class 2 Recall
Gentell Hydrogel Ag 2x2, model no GEN-11220 - 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
Abbott Diabetes Care, Inc. - Optium EZ Blood Glucose Monitoring System - Class 2 Recall
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 29, 2020 Category: Medical Devices Source Type: alerts
Abbott Diabetes Care, Inc. - Precision Xtra Blood Glucose & Ketone Monitoring System - Class 2 Recall
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 29, 2020 Category: Medical Devices Source Type: alerts
Abbott Diabetes Care, Inc. - FreeStyle Precision H Blood Glucose and Ketone Monitoring System - Class 2 Recall
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 29, 2020 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - The AccuChek Aviva Plus Test Strips - Class 2 Recall
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - ACCUCHEK AVIVA ASPAC STRIP - Class 2 Recall
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek Aviva Plus Test Strips are for use with the AccuChek Aviva Blood Glucose Meter - Class 2 Recall
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Dexcom Inc - Dexcom G5 Mobile Receiver - Class 2 Recall
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2020 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek - Class 2 Recall
Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2019 Category: Medical Devices Source Type: alerts
