Regulatory: Device Recalls

Brainlab AG - Spine & Trauma 3D Navigation 1.0 - Class 1 Recall
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.

ICU Medical, Inc. - icumedical Oncology Kit - Class 1 Recall
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously...

ICU Medical, Inc. - SetSource ChemoClave Vented Vial Spike - Class 1 Recall
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. 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...

ICU Medical, Inc. - icumedical Oncology Kit - Class 1 Recall
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of...

ICU Medical, Inc. - ChemoClave(R) Vented Vial Spike, 20 mm - Class 1 Recall
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. 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...

ICU Medical, Inc. - icumedical ChemoLock Closed Vial Spike w/Skirt - Class 1 Recall
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system,...

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ECMO Research

Deployment of acute mechanical circulatory support devices via the axillary artery.
Author: Tayal R, Hirst CS, Garg A, Kapur NK
Deployment of acute mechanical circulatory support devices via the axillary artery. Expert Rev Cardiovasc Ther. 2019 Apr 23;:1-8 Authors: Tayal R, Hirst CS, Garg A, Kapur NK Abstract INTRODUCTION: Use of acute mechanical circulatory support (MCS) devices for high-risk...