medical Class II Updated 2018-05-30

Madison Polymeric Engineering recalls Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope

Recalled 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)


Hazard / Issue

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

Issued by

FDA

Affected 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, WI
Lot/Code Info: Lot Numbers: EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, EX20181229P
View official government recall

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