Medical device recalls Moderate risk

Medline Industries Inc recalls Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the…

Recall date
April 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2203-2019
FDA classification
Class II
Brand / firm
Medline Industries Inc
Sold / distributed
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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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