—#150498

Product

Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent; Bard Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

FDA product code: FAD — Stent, Ureteral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K823487
Affected lot / code info: Product Codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407 and 288408.

Why it was recalled

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use. If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This notification should be carried out to the user level. This product notification is being made with the knowledge of the Food and Drug administration. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. For further questions, please call (770) 784-6220.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: U.S. Nationwide.

Timeline

Recall initiated: 2016-10-13
Terminated: 2022-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.