FDA Medical Device Recalls (openFDA)
Cook Urological, Inc.: Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
- Recall number
- Z-1162-2007
- Recalling firm
- Cook Urological, Inc.
- Product
- Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
- Status
- Terminated
- Initiated
- 2007-06-12
- Posted
- 2007-08-09
- Terminated
- 2009-11-25
- Reason
- Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
- Root cause
- Process control
- Action
- Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.
- Quantity
- 100
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lot U1621121
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EZB
- Firm FEI
- not on file
- 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