3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Completed
·ICU Medical, Inc.·Product code FMG·August 20, 2018
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Enforcement
Class II
·Completed·Varian Medical Systems Imaging Laboratory GmbH·April 20, 2022
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Recall
Completed
·Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland·Product code IYE·March 21, 2022