Z-1900-2018 Class II Terminated
FDA device recall Z-1900-2018 was initiated by Madison Polymeric Engineering on March 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 April 9, 2019). Affected quantity: 13 cases/1300 pads.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- March 21, 2018
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 cases/1300 pads
Product Description
Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
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: EX20181226P, EX20181227P, EX20181228P, EX20181229P, EX20190102P