FDA-Device2018-05-30Class II
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Madison Polymeric Engineering
Hazard
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Sold states
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.
Affected count
3 cases/210 kits
Manufactured in
965 W Main St, N/A, Branford, CT, United States
Products
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2018Don't want to check this manually?
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