ICU Medical—ChemoLock Vial Spikes: May Generate Burr Particulate

January 30, 2019 | Strategic Insights for Health System


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In a January 3, 2019, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, ICU Medical states that the above vial spike may generate burr particulate, originating from the protective cap used in the assembly of the device. ICU Medical also states that burr particulate may detach; in uncommon circumstances, a detached burr could enter the fluid path, be infused into an intravenous line, enter the patient, and lead to an embolism. ICU Medical further states that it has received...

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