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Madison Polymeric Engineering recalls First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes an
Recalled April 4, 2018 · FDA recall Z-1182-2018 · Madison Polymeric Engineering
Hazard
Affected lots may have exceeded its microbial limits. · FDA Class II
Units
285 cases
Sold at
US Distribution. .
Description
Affected lots may have exceeded its microbial limits.
Product
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.".
Manufacturer(s)
Madison Polymeric Engineering
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →