HAND SANITIZER gel [Zhe jiang OPS Environmental Technology Co.,Ltd.]
Updated Date: Tue, 15 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2020 Category: Drugs & Pharmacology Source Type: alerts

Terumo Cardiovascular Systems Corporation - Capiox FX25 Advance Oxygenator - Class 2 Recall
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2020 Category: Medical Devices Source Type: alerts

Remote Diagnostic Technologies Ltd. - Tempus LSManual - Class 2 Recall
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 12, 2020 Category: Medical Devices Source Type: alerts

OHTRUST NANO ION WATER (hydroxide ions) liquid [Kunshan Nano Environmental Protection Technology Co. Ltd.]
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

OHTRUST NANO ION WATER (hydroxide ions) liquid [Kunshan Nano Environmental Protection Technology Co. Ltd]
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

OHTRUST NANO ION WATER (hydroxide ions) liquid [Kunshan Nano Environmental Protection Technology Co. Ltd.]
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

GE Healthcare, LLC - Aestiva MRI - Class 2 Recall
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss. (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
6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2020 Category: Medical Devices Source Type: alerts

ARJOHUNTLEIGH POLSKA Sp. z.o.o. - Citadel Plus Bariatric Bed Frame System - Class 2 Recall
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2020 Category: Medical Devices Source Type: alerts

KCI USA, INC. - Negative Pressure Wound Therapy Powered Suction Pump - Class 2 Recall
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2020 Category: Medical Devices Source Type: alerts