Z-2766-2020 Class II Terminated
FDA device recall Z-2766-2020 was initiated by Medline Industries Inc on July 9, 2020 and is designated Class II. Reason for recall: Potential risk of brush detachment during cleaning. The recall status is terminated (terminated January 25, 2021). Affected quantity: 1,400 total units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- July 9, 2020
- Termination Date
- January 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,400 total units
Product Description
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 Pattern
US Nationwide distribution including in the states of CA, IN and OH.
Code Information
Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20