Z-1870-2017Class II

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Name: Z-1870-2017 Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Creator: Cook Inc.
Published: 2017-03-07
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-03-07 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set on 2017-03-07. FDA classified it as Class II and gives the reason as "Product may overheat, melt, and burn patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1870-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-04-19
Terminated: 2018-10-16
Recalling firm: Cook Incorporated
Product: Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Product code: FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Reason for recall: Product may overheat, melt, and burn patient.
Root cause tag: design
FDA 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 ([email protected]). 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 [email protected]. 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 in commerce: 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.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1870-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1870-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-20

Product code FCS

K923436Class IIIlluminated Ureteral CatheterCook Urological, Inc. / cleared 1993-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)