Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.
FDA Recall Z-2331-2008 · Posted 2008-09-23
Advertisement
Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-07-02
Date Terminated2009-06-04
Product Quantity20 units
Reason for Recall
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
Firm Action
Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement