Recall Z-1900-2018— Madison Polymeric Engineering

Name: FDA recall Z-1900-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-21

Class II · Terminated

Class II FDA medical device recall by Madison Polymeric Engineering, initiated 2018-03-21, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z. Reason: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica..

Recalling firm: Madison Polymeric Engineering
Classification: Class II
Status: Terminated
Initiated: 2018-03-21
Terminated: 2019-04-09
Firm location: Branford, CT, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.