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U.S. Department of Health and Human Services

Class 2 Device Recall Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System

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  Class 2 Device Recall Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System see related information
Date Initiated by Firm May 03, 2017
Date Posted June 05, 2017
Recall Status1 Terminated 3 on January 26, 2018
Recall Number Z-2540-2017
Recall Event ID 77305
510(K)Number K072521  
Product Classification image, illumination, fiberoptic, for endoscope - Product Code FFS
Product Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Code Information Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
812-339-2235
Manufacturer Reason
for Recall		 Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
FDA Determined
Cause 2		 Device Design
Action Cook Inc. initiated a voluntary recall of multiple products because it was identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Notices were mailed on 05/9/2017 via courier. Customers were asked to do the following: Distribution of the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System products will not occur until the reprocessing instructions in the Instructions for Use have been corrected. You can continue to use the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System by following the attached document for Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the provided updated Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email (fieldactionsna@cookmedical.com). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in Commerce 1328 units
Distribution Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None
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 = FFS and Original Applicant = COOK UROLOGICAL, INC.
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