FDA-Device2019-08-14Class II

Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

Medline Industries Inc
Hazard

Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

Sold states
US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY
Affected count
22204
Manufactured in
Three Lakes Drive, N/A, Northfield, IL, United States
Products
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2203-2019

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