Devices

Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.

Model / Serial
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution. .
Product Description
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
Madison Polymeric Engineering
1 Event
- Recall of Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.

Manufacturer

Madison Polymeric Engineering

Manufacturer Address
Madison Polymeric Engineering, 965 W Main St, Branford CT 06405-3453
Manufacturer Parent Company (2017)
Madison Polymeric Engineering Inc.
Source
USFDA

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