Centurion Medical Products Corporation - Centurion Dressing Change Kits - Class 2 Recall
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING CHANGE KIT DYNDC1870A SMALL DRESSING KIT DYNDC1945B PORT ACCESS KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1996B CENTRAL LINE DRESSING CHANGE DYNDC2004A IVAD KIT DYNDC20...
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Centurion Neonatal PICC Tray - Class 2 Recall
Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY CVI4395A NICU PICC INSERTION KIT CVI4395A NICU PICC INSERTION KIT CVI4565 NEONATAL PICC TRAY (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CARESCAPE Central Station - Class 2 Recall
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CIC Pro Clinical Information Center Central Station - Class 2 Recall
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - Accutorr 3 Vital Signs Monitor - Class 2 Recall
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 30, 2019 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - Accutorr 7 Vital Signs Monitor - Class 2 Recall
Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 30, 2019 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - Rosie4 Vital Signs Monitor - Class 2 Recall
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 30, 2019 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - Rosebud Vital Signs Monitor - Class 2 Recall
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 30, 2019 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Class 2 Recall
NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2019 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Class 2 Recall
Neonatal Cap Change Kit DT20315 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek Aviva II Meter - Class 2 Recall
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-...
Source: Medical Device Recalls - October 1, 2019 Category: Medical Devices Source Type: alerts
Roche Diabetes Care, Inc. - AccuChek Performa II Meter - Class 2 Recall
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Ac...
Source: Medical Device Recalls - October 1, 2019 Category: Medical Devices Source Type: alerts
Fenwal Inc - VOLUMAT MC AGILIA US - Class 1 Recall
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV ro...
Source: Medical Device Recalls - August 13, 2019 Category: Medical Devices Source Type: alerts
Medline Industries Inc - Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit - Class 1 Recall
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood and blood products to adult, pediatric or neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2019 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Philips EPIQ and Affiniti Ultrasound Systems - Class 2 Recall
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperat...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
