FDA Medical Device Recalls (openFDA)
Cook Urological, Inc.: Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
- Recall number
- Z-0377-2007
- Recalling firm
- Cook Urological, Inc.
- Product
- Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
- Status
- Terminated
- Initiated
- 2007-01-05
- Posted
- 2007-01-25
- Terminated
- 2008-05-01
- Reason
- Lack of assurance of sterility, as the packages may not have been sealed.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
- Quantity
- 4
- Distribution
- Massachusetts, Maine, New Hampshire and Puerto Rico.
- Lot, serial or model codes
- Lot U1546391.
- 510(k) numbers
- ["K043418"]
- PMA numbers
- not on file
- Product code
- FED
- 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