Invivo Corporation - PHILIPS Xper Flex Cardio Physiomonitoring System - Class 2 Recall
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
ZOLL Medical Corporation - OneStep CPR Complete - Class 2 Recall
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2018 Category: Medical Devices Source Type: alerts
AMEDA, INC. - Purely Yours Breast Pumps - Class 3 Recall
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts
Invivo Corporation - Flex Cardio Patient Monitoring System - Class 2 Recall
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbo...
Source: Medical Device Recalls - November 10, 2017 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Delta - Class 2 Recall
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient s medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, an...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
Draegar Medical Systems, Inc. - Delta XL - Class 2 Recall
Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient s medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, ...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
Draegar Medical Systems, Inc. - Kappa - Class 2 Recall
Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient s medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parame...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
Ohmeda Medical - OhmedaOhio CarePlus Incubator - Class 2 Recall
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The ...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Ohmeda Medical - Infant Warmer System - Class 2 Recall
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate he...
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Stanley Security Solutions Inc - Arial WaterResistant Pendant, model 59350 - Class 2 Recall
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
NURSING CREAM (Calendula Officinalis, Chamomilla Recutita, Althaea Officinalis) Salve [Sierra Sage Herbs LLC]
Updated Date: Feb 10, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 10, 2017 Category: Drugs & Pharmacology Source Type: alerts
Nurse Assist, Inc - IV Flush - Class 1 Recall
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2017 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - Class 2 Recall
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2016 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - Class 2 Recall
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2016 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection o...
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
