—#182527

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.

FDA product code: MNL — Accessories, Cleaning Brushes, For Endoscope
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20

Why it was recalled

Potential risk of brush detachment during cleaning.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: US Nationwide distribution including in the states of CA, IN and OH.

Timeline

Recall initiated: 2020-07-09
Terminated: 2021-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182527. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.