Madison Polymeric Engineering recalls First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

Recall date

March 21, 2018

Source

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

Recall number

Z-1895-2018

FDA classification

Class II

Brand / firm

Madison Polymeric Engineering

Sold / distributed

The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.

Why it was recalled

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

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

What was recalled

First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3