Regulatory: Device Recalls

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...

Fenwal Inc - Vigilant Agilia, Vigilant Drug'Lib - Class 1 Recall
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a...

Medline Industries Inc - Medline Primary Warmer Pack - Class 1 Recall
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating...

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,...

St Jude Medical Inc. - Ellipse ICD - Class 1 Recall
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc. - Ellipse ICD - Class 1 Recall
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

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ECMO Research

Biventricular Impella Use in Pediatric Patients with Severe Graft Dysfunction from Acute Rejection After Heart Transplantation.
Author: Ankola AA, McAllister J, Turner ME, Zuckerman WA, Richmond ME, Addonizio LJ, Lee TM, Law SP
Biventricular Impella Use in Pediatric Patients with Severe Graft Dysfunction from Acute Rejection After Heart Transplantation. Artif Organs. 2019 Aug 20;: Authors: Ankola AA, McAllister J, Turner ME, Zuckerman WA, Richmond ME, Addonizio LJ, Lee TM, Law SP Abstract ...

Points & pearls: Anaphylaxis in pediatric patients: early recognition and treatment are critical for best outcomes
Author: Nunez J, Santillanes G
Points & pearls: Anaphylaxis in pediatric patients: early recognition and treatment are critical for best outcomes Pediatr Emerg Med Pract. 2019 06 01;16(Suppl 6):1-2 Authors: Nunez J, Santillanes G Abstract Anaphylaxis is a time-sensitive, clinical diagnosis...