Recall Z-0852-2009

Vance Products Incorporated · initiated July 31, 2008

Terminated

Product

Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent.

Codes / lots: Lots UF1406358.

Reason for recall

The bond may break where the two materials meet, resulting in separation of the stent.

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-0852-2009
Initiated
July 31, 2008
Posted by FDA
January 23, 2009
Terminated
November 27, 2009
Product code
FAD – Stent, Ureteral
Quantity
1739 of all products.
Distribution
Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
Recalling firm
Vance Products Incorporated, Spencer, IN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0839-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0840-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0841-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0842-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0843-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0844-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0845-2009 Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0846-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0847-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0848-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0849-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0850-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0851-2009 Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated
Z-0853-2009 Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook…The bond may break where the two materials meet, resulting in separation of the stent. 07/31/2008Terminated