Medical device recalls Moderate risk

International Medsurg Connection, Inc. recalls Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are use…

Recall date
June 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2845-2017
FDA classification
Class II
Brand / firm
International Medsurg Connection, Inc.
Sold / distributed
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.

Why it was recalled

Insufficient documentation to support product sterility claims.

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

What was recalled

Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

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