Recall Z-0403-2017
C.R. Bard, Inc. · initiated October 13, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407 and 288408.
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0403-2017
- Initiated
- October 13, 2016
- Terminated
- February 10, 2022
- Product code
- FAD – Stent, Ureteral
- Quantity
- 75,089 units
- Distribution
- U.S. Nationwide.
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0404-2017 Class II | BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0405-2017 Class II | Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0406-2017 Class II | Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |