Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent.
FDA Recall Z-0840-2009 · Posted 2009-01-23
Recalling FirmVance Products Incorporated
Recall StatusTerminated
Product CodeFAD
Date Initiated2008-07-31
Date Terminated2009-11-27
Product Quantity1739 of all products.
Reason for Recall
The bond may break where the two materials meet, resulting in separation of the stent.
Firm Action
Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.
Root Cause
Process control
Distribution Pattern
Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
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.