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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 Smartcapsee related information
Date Initiated by FirmOctober 09, 2019
Create DateApril 23, 2020
Recall Status1 Terminated 3 on December 11, 2020
Recall NumberZ-1778-2020
Recall Event ID 84109
510(K)NumberK093665 
Product Classification Cystoscope and accessories, flexible/rigid - Product Code FAJ
ProductMedivators Endo carry-on Procedure Kit REF CPK-100222-0002 - 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 # 1000028736 GTIN: 00677964086045  Use-by date: 210120  
Recalling Firm/
Manufacturer		 Medivators, Inc.
14605 28th Ave N
Plymouth MN 55447-4822
For Additional Information ContactCustomer 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
ActionAn 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 Commerce53,790 units total
DistributionWorldwide distribution - US Nationwide distribution and the countries of Australia, England.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FAJ
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