Reported Apr 4, 2018 · Terminated

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

Madison Polymeric Engineering

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Madison Polymeric Engineering · 965 W Main St · Branford, CT · 06405-3453

Is this the product you have?

  • 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."
Lot codes and dates
    • EP-4 Lots EXP20 l 7 l 209A
    • EXP20 l 80512A
    • and EP-4D Lot EXP20 l80520A
Amount recalled
285 cases

Why it was recalled

Affected lots may have exceeded its microbial limits.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 17, 2018 · Data as of Sep 19, 4:48 PM UTC

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