Particulate matter was found in an Amino Acid Injection in September. ICU Medical, Inc. voluntarily recalled one lot of Aminosyn II, 15% of 2,112 units. This is a Sulfite Free IV solution used in hospitals. The recall was enforced due to particles such as fibers, hairs and proteinaceous materials. These particles were found when ICU Medical, Inc. was completing a routine sample inspection of their products.
When a product is administered and contains particulate matter, there could be many medical issues following the administration. Issues including: inflammation at the site, formation of a blood clot—which could lead to obstruction the flow of blood and lead to organ damage or death. Since the projected recall, ICU Medical, Inc. has not received such reports of illness or death.
This product was distributed to hospitals from January 2021- March 2021 to hospitals for administration to patients.
InQuest Science's Identifier Software maintains data integrity and ensures product quality by setting inspection qualifications and requirements. With instances like these— it is unknown if data was altered in order to pass along for distribution.
