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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscopic Cleaning Brush

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  Class 2 Device Recall Endoscopic Cleaning Brush see related information
Date Initiated by Firm July 09, 2020
Create Date August 05, 2020
Recall Status1 Terminated 3 on January 25, 2021
Recall Number Z-2766-2020
Recall Event ID 86024
Product Classification Accessories, cleaning brushes, for endoscope - Product Code MNL
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.
Code Information Model# : DYK1002DCB and DYK1002DBDE LOT #: GM10, GJ25, HA05, and HA20 
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Potential risk of brush detachment during cleaning.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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