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U.S. Department of Health and Human Services

Class 2 Device Recall Medivators Endo Smartcap

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  Class 2 Device Recall Medivators Endo Smartcap see related information
Date Initiated by Firm October 09, 2019
Create Date April 23, 2020
Recall Status1 Terminated 3 on December 11, 2020
Recall Number Z-1775-2020
Recall Event ID 84109
510(K)Number K093665  
Product Classification Cystoscope and accessories, flexible/rigid - Product Code FAJ
Product Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Code Information Lot # / UDI #s: 427118 / 006779640590872208031427118,  427117 / 006779640590872208031427117,  427116 / 006779640590872208031427116,  428819 / 006779640590872208131428819,  430069 /006779640590872208241430069,  426432 / 006779640590872207251426432,  426431 / 006779640590872207251426431,  426433 / 006779640590872207251426433,  427129 / 006779640590872208031427129,  427505 / 006779640590872208051427505,  427132 / 006779640590872208031427132,  428284 / 006779640590872208111428284,  428110 / 006779640590872208081428110,  427130 / 006779640590872208031427130,  427131 / 006779640590872208031427131,  428821 / 006779640590872208131428821,  428823 / 006779640590872208131428823,  428282 / 006779640590872208111428282,  428576 / 006779640590872208121428576,  427119 / 006779640590872208031427119.  
Recalling Firm/
Manufacturer		 Medivators, Inc.
14605 28th Ave N
Plymouth MN 55447-4822
For Additional Information Contact Customer Service
800-444-4729
Manufacturer Reason
for Recall		 Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
FDA Determined
Cause 2		 Equipment maintenance
Action An Urgent Medical Device Recall Notification letter was sent to customers via certified mail next day delivery on 10/09/2019. The letter identified affected product, stated reason for recall, asked for product to be quarantined and discontinue use. Customers are to return product to Medivators by obtaining a Return Material Authorization from Customer Service. A response form was asked to be returned. Questions can be directed to Customer Service at 1-800-444-4729.
Quantity in Commerce 53,790 units total
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
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.
510(K) Database 510(K)s with Product Code = FAJ and Original Applicant = BYRNE MEDICAL INC.
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