ICU Medical—ChemoLock Vial Spikes: May Generate Burr Particulate

​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org

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...