Smiths—29 G Hypodermic Needle-Pro Fixed Needle Insulin Syringes: May Contain Visible Particulates

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 a July 10, 2013, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, Smiths states that orange/brown particulates may appear on some of the needles below, potentially leading to a site reaction in sensitive patients, including infection or allergic reaction. Smiths states that the particulates consisted of inorganic materials and that it has received no reports of infection, allergic reaction, or injury related to this problem. Smiths also states that only needles with the above product and lot numbers may be affected. The manufacturer has not confirmed the...