FDA-Device2018-04-04Class II
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.".
Madison Polymeric Engineering
Hazard
Affected lots may have exceeded its microbial limits.
Sold states
US Distribution. .
Affected count
285 cases
Manufactured in
965 W Main St, Branford, CT, United States
Products
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.".
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2018Don't want to check this manually?
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