Z-1182-2018 Class II Terminated
FDA device recall Z-1182-2018 was initiated by Madison Polymeric Engineering on Nov 3, 2017 and is designated Class II. Reason for recall: Affected lots may have exceeded its microbial limits. The recall status is terminated (terminated Jul 17, 2018). Affected quantity: 285 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Nov 3, 2017
- Termination Date
- Jul 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 285 cases
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.".
Reason for Recall
Affected lots may have exceeded its microbial limits.
Distribution Pattern
US Distribution. .
Code Information
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1182-2018
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026