Z-1898-2018 Class II Terminated
FDA device recall Z-1898-2018 was initiated by Madison Polymeric Engineering on Mar 21, 2018 and is designated Class II. Reason for recall: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 359 cases/10770 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Mar 21, 2018
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 359 cases/10770 kits
Product Description
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Reason for Recall
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Distribution Pattern
The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
Code Information
Lot Numbers: EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181228P, EX20190103P, EX20190105P
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1898-2018
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026