FDA Medical Device Recalls (openFDA)
Cook Urological, Inc.: Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
- Recall number
- Z-0554-03
- Recalling firm
- Cook Urological, Inc.
- Product
- Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
- Status
- Terminated
- Initiated
- 2003-01-22
- Posted
- 2003-02-13
- Terminated
- 2003-03-26
- Reason
- Product is labeled sterile, but was not sterilized.
- Root cause
- Other
- Action
- Customers were notified by phone call and recall letter beginning on 1/22/03.
- Quantity
- 15
- Distribution
- Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
- Lot, serial or model codes
- Lot 1049345
- 510(k) numbers
- ["K990072"]
- PMA numbers
- not on file
- Product code
- EZN
- 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