Recall Z-0843-2009
Vance Products Incorporated · initiated July 31, 2008
Product
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent.
Codes / lots: Lots U1368875, U1532226, U1541632, U1402438, U1356439, U1380409, U1418931, U1538110, U1362570, U1408480, U1411865, U1426173, U1527133, U1357612, U1416045, U1421059, UF1383702, UF1391074, U1426173 and U1525571.
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-0843-2009
- 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
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-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-0852-2009 | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 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 |