Recall Z-0403-2017 ยท FAD Stent, Ureteral
C.R. Bard, Inc.
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.
| Date | Oct 13, 2016 |
| Status | Terminated |
| Reason | 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 | Labeling Change Control |
| Action | 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 th |
| Quantity | 75,089 units |
| Distribution | U.S. Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K823487 | BARD URETERAL STENT C.R. Bard, Inc., May 27, 1983 |