RecallWatchUSA

Home / Recalls / Medical Devices

Madison Polymeric Engineering recalls Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catal

Recalled May 30, 2018 · FDA recall Z-1899-2018 · Madison Polymeric Engineering

Hazard
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. · FDA Class II
Units
23 cases/1150 kits
Sold at
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.

Description

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

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)
Manufacturer(s)
Madison Polymeric Engineering

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Madison Polymeric Engineering recalls Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catal | RecallWatchUSA