Recall Z-1899-2018— Madison Polymeric Engineering

Name: FDA recall Z-1899-2018
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: Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W). 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

Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

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.