Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update
C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents to add a warning about potential knots during removal.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to address a potential handling issue (knotting) during removal. It is a voluntary precautionary labeling correction without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk issues.
Plain-English summary
C.R. Bard, Inc. is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents, Bard Fluoro-4 Silicone Ureteral Coil Stents, and Bard Silicone Ureteral Coil Stents with Figure Four Ends. The affected products were distributed nationwide in the United States.
The recall is a Class II labeling action. A statement was added to the Warnings/Precautions section of the product labeling to request that end users consider the presence of a knot if significant resistance is encountered during attempts at removal. This update is intended to inform healthcare providers of a specific handling consideration during the removal process.
Healthcare providers and facilities should check their inventory for the affected product codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407, and 288408. Users should refer to the updated labeling for guidance on managing resistance during stent removal.
The recalled product
- 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.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Ureteral Stents
- Affected units
- 75,089
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Product Codes: 277405
- 277406
- 277407
- 277408
- 288405
- 288406
- 288407 and 288408.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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