FDA recall Z-2766-2020

Medline Industries Inc · Class II · device

Product

Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

Reason for recall

Potential risk of brush detachment during cleaning.

Distribution

US Nationwide distribution including in the states of CA, IN and OH.

Key facts

Status
Terminated
Initiation date
2020-07-09
Report date
2020-08-12
Termination date
2021-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2766-2020