Recalls / —

—#154579

Product

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

FDA product code

FCS — Light, Catheter, Fiberoptic, Glass, Ureteral

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K923436

Affected lot / code info

All lots.

Why it was recalled

Product may overheat, melt, and burn patient.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Cook Inc.

Address

750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2017-03-07

Posted by FDA

2017-04-19

Terminated

2018-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.