Recall Z-2540-2017— Cook Inc.

Name: FDA recall Z-2540-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-03

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2017-05-03, terminated 2018-01-26. It names one FDA 510(k) clearance: K072521. Product: Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages. Reason: 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Terminated: 2018-01-26
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATHCook Urological, Inc.·cleared 2007-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.