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.
Recall
- Recall Number
- Z-2766-2020
- Event Number
- 86024
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- MNL
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 9, 2020
- Terminated
- January 25, 2021
- Address
- Three Lakes Drive, Northfield, IL, 60093
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.
Potential risk of brush detachment during cleaning.
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.
US Nationwide distribution including in the states of CA, IN and OH.
1,400 total units