FDA Medical Device Recalls (openFDA)
Vance Products Incorporated: Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
- Recall number
- Z-1168-2007
- Recalling firm
- Vance Products Incorporated
- Product
- Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
- Status
- Terminated
- Initiated
- 2007-06-29
- Posted
- not on file
- Terminated
- 2008-06-11
- Reason
- The radiographic band may detach from the stent and remain in the patient after removal of the stent.
- Root cause
- Other
- Action
- Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.
- Quantity
- 75
- Distribution
- Worldwide, including USA, Canada, and Japan.
- Lot, serial or model codes
- Lots U1629501, U1629502 and U1631782.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 1825146
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28