Recall Z-2766-2020 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Medline Industries Inc
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.
| Date | Jul 9, 2020 |
| Status | Terminated |
| Reason | Potential risk of brush detachment during cleaning. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 1,400 total units |
| Distribution | US Nationwide distribution including in the states of CA, IN and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.