Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2766-2020Class II

Endoscopic Cleaning Brush -

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-07-09 / Terminated

Medline Industries Inc began a recall of Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy... on . FDA classified it as Class II and gives the reason as "Potential risk of brush detachment during cleaning". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2766-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
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.
Product code
MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall
Potential risk of brush detachment during cleaning.
FDA 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 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.
Quantity in commerce
1,400 total units
Distribution
US Nationwide distribution including in the states of CA, IN and OH.
Product codes and lots
Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2766-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2766-2020Class IITerminatedVoluntary: Firm initiated