Hospira—Empty Evacuated Containers: Visible Particles May Be Embedded in Glass

September 5, 2012 | Risk Management News


ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In an August 28, 2012, Urgent Device Recall letter submitted by the manufacturer and ECRI Institute member hospitals, Hospira states that visible particles may be embedded in the glass of the containers below. Products may come into contact with the embedded particles and/or the particles may become dislodged into the solution. If particulate matter is injected into a patient, patient injury may occur, potentially requiring medical intervention. Signs and symptoms may include local inflammation, bruising, itching, rash, chest pain, and respiratory symptoms. Particulate matter may embolize to other organs in the body, potentially resulting in vascular occlusion. Following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs.


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