Smiths Medical ASD Inc. recalls Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Recall date

April 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2662-2018

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.

Why it was recalled

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism