FDAFDA · Food and drugs·Recall number Z-1182-2018
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.".
Published April 4, 2018 · Recall initiated: November 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Affected lots may have exceeded its microbial limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Madison Polymeric Engineering
- Distributor
- US Distribution. .
- Lot
- EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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