FDA Medical Device Recalls (openFDA)
Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN: Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
- Recall number
- Z-0966-2011
- Recalling firm
- Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
- Product
- Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
- Status
- Terminated
- Initiated
- 2010-12-13
- Posted
- 2011-01-25
- Terminated
- 2011-01-31
- Reason
- The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.
- Root cause
- Packaging process control
- Action
- The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.
- Quantity
- 25 stents
- Distribution
- CA, CT
- Lot, serial or model codes
- U1973244
- 510(k) numbers
- K820313
- PMA numbers
- not on file
- Product code
- KOD
- 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