BIONEL PEDIATRIC (dextromethorphan, guaifenesin, pseudoephedrine hydrochloride) liquid [Advanced Generic Corporation]
Updated Date: Thu, 24 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 24, 2020 Category: Drugs & Pharmacology Source Type: alerts
OXYGEN gas [RTA Pediatric Care Inc.]
Updated Date: Thu, 10 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 10, 2020 Category: Drugs & Pharmacology Source Type: alerts
Philips North America Llc - Philips IntelliVue X2 - Class 2 Recall
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 9, 2020 Category: Medical Devices Source Type: alerts
Philips North America Llc - Philips IntelliVue MP2 - Class 2 Recall
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 9, 2020 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ AntiIV Connector - Class 2 Recall
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling - Class 2 Recall
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTIS Icono (VE2) System - Class 2 Recall
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Aisys CS2 - Class 2 Recall
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 31, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Avance CS2 - Class 2 Recall
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 31, 2020 Category: Medical Devices Source Type: alerts
ICU Medical, Inc. - IV Administration Set - Class 2 Recall
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250101(30)100(10)4590919; (01)10887709058757(17)250201(30)100(10)4712217; (01)10887709058757(17)241201(30)100(10)4537440; (01)10887709058757(17)241201(30)100(10)4549906; (01)10887709058757(17)250101(30)100(10)4559515; (01)10887709058757(17)250201(30)100(10)4719743; (01)10887709058757(17)250201(30)100(10)4726897; (01)10887709058757(17)250201(30)100(10)4735597; (01)10887709058757(17)241101(30)100(10)4461205. CLAVE Neutron is a normally closed, bidirectional connector intended for u...
Source: Medical Device Recalls - October 23, 2020 Category: Medical Devices Source Type: alerts
ICU Medical, Inc. - IV Administration Set - Class 2 Recall
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2020 Category: Medical Devices Source Type: alerts
Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts
Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts
Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts
Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts
