Ortho Clinical Diagnostics - VITROS AntiSARSCoV2 Total Reagent - Class 2 Recall
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2020 Category: Medical Devices Source Type: alerts
Ortho Clinical Diagnostics - VITROS AntiSARSCoV2 IgG Reagent Pack - Class 2 Recall
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2020 Category: Medical Devices Source Type: alerts
Physio-Control, Inc. - Infant/Child Reduced Energy Defibrillation Electrodes - Class 2 Recall
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2020 Category: Medical Devices Source Type: alerts
Physio-Control, Inc. - Infant/Child Reduced Energy Defibrillation Electrodes - Class 2 Recall
Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Ysio Max - Class 2 Recall
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
Western / Scott Fetzer Company - Grab n Go Opti - Class 2 Recall
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2019 Category: Medical Devices Source Type: alerts
Western / Scott Fetzer Company - Grab n Go Opti - Class 2 Recall
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2019 Category: Medical Devices Source Type: alerts
Western / Scott Fetzer Company - Grab n Go Opti - Class 2 Recall
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2019 Category: Medical Devices Source Type: alerts
Western / Scott Fetzer Company - Grab n Go Opti - Class 2 Recall
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2019 Category: Medical Devices Source Type: alerts
Western / Scott Fetzer Company - Grab n Go Opti - Class 2 Recall
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2019 Category: Medical Devices Source Type: alerts
POM Medical LLC - POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask - Class 2 Recall
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2019 Category: Medical Devices Source Type: alerts
PLUS RINSE EMERGENCY (Purified Water) Liquid [INNOVATIVE SAFETY SUPPLY INC.]
Updated Date: Jun 19, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 19, 2019 Category: Drugs & Pharmacology Source Type: alerts
National Infrastructure Protection Plan
HSPD-7 identified 17 CI/KR sectors and designated SSAs for each of the sectors. Each sector is responsible for developing and submitting Sector-Specific Plans and sector-level performance feedback to the DHS to enable national cross-sector CI/KR protection program gap assessments. HSPD-9 establishes a national policy to defend the food and agriculture system against terrorist attacks, major disasters, and other emergencies. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Siemens Medical Solutions USA, Inc - CIOS ALPHA - Class 2 Recall
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Class 2 Recall
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2019 Category: Medical Devices Source Type: alerts
