Owen Mumford USA, Inc. recalls Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic,…

Recall date

November 6, 2017

Source

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

Recall number

Z-0382-2018

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, NX, UT, VA, VT, WA, WV

Why it was recalled

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

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 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.