Madison Polymeric Engineering recalls First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes a…

Recall date

November 3, 2017

Source

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

Recall number

Z-1182-2018

FDA classification

Class II

Brand / firm

Madison Polymeric Engineering

Sold / distributed

US Distribution. .

Why it was recalled

Affected lots may have exceeded its microbial limits.

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 Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".