Z-2540-2017Class II

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied...

Name: Z-2540-2017 Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied...
Creator: Cook Inc.
Published: 2017-05-03
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-05-03 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages on 2017-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2540-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Posted: 2017-06-05
Terminated: 2018-01-26
Recalling firm: Cook Incorporated
Product: Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Product code: FFS Image, Illumination, Fiberoptic, For Endoscope
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.
Root cause tag: design
FDA root cause: 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 ([email protected]). 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 [email protected]. 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2540-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2540-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code FFS

K072521Class IICook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. / cleared 2007-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)