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.
Z-2766-2020
Product summary
- Event
- Event 86024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,400 total units
- Official record key
device-enforcement:Z-2766-2020
Official wording
Reason: Potential risk of brush detachment during cleaning.
Code information: Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20
Distribution pattern: US Nationwide distribution including in the states of CA, IN and OH.
Derived failure modes
-
Unknown
Potential risk of brush detachment during cleaning.