FDA recall Z-2203-2019

Medline Industries Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-04-25
Report date
2019-08-14
Termination date
2020-12-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

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