Medical device recalls Moderate risk

Owen Mumford USA, Inc. recalls Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

Recall date
May 26, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2078-2021
FDA classification
Class II
Brand / firm
Owen Mumford USA, Inc.
Sold / distributed
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.

Why it was recalled

Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

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

What was recalled

Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

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