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.
- Company
- Medline Industries Inc
- Recall Initiated
- July 9, 2020
- Terminated
- January 25, 2021
- Recall Number
- Z-2766-2020
- Quantity
- 1,400 total units
- Firm Location
- Northfield, IL
Reason for Recall
Potential risk of brush detachment during cleaning.
Distribution
US Nationwide distribution including in the states of CA, IN and OH.
Lot / Code Info
Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20
Root Cause
Under Investigation by firm
Action Taken
On July 9th 2020, the firm sent a letter to their customer with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for item number DYK1002DBDE & DYK1002DCB. The four affected lot numbers are GM10, GJ25, HA05, and HA20. Quarantine and destroy all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product(s) destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Your account will receive credit when the destruction form is returned. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.