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Terminated

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 Recall Z-2766-2020 · Posted None

Recall StatusTerminated
Product CodeMNL
Date Initiated2020-07-09
Date Terminated2021-01-25
Product Quantity1,400 total units

Reason for Recall

Potential risk of brush detachment during cleaning.

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 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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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