FDA Medical Device Recalls (openFDA)
Cook Inc.: Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
- Recall number
- Z-1870-2017
- Recalling firm
- Cook Inc.
- Product
- Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
- Status
- Terminated
- Initiated
- 2017-03-07
- Posted
- 2017-04-19
- Terminated
- 2018-10-16
- Reason
- Product may overheat, melt, and burn patient.
- Root cause
- Device Design
- Action
- On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Action To Be Taken: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email to (fieldactionsna@cookmedical.com). 4. Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. 5. Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via customerrelationsna@cookmedical.com. This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Quantity
- 19756
- Distribution
- The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates and the United Kingdom.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K923436"]
- PMA numbers
- not on file
- Product code
- FCS
- Firm FEI
- 1820334
- Firm city
- Bloomington
- 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