BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0404-2017.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0404-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact C.r. Bard, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0404-2017.
C.R. Bard, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
C.r. Bard, Inc. Recall FAQ
C.r. Bard, Inc. is the subject of a medical implants safety report: BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.. The notice was published on October 13, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 75,089 units are potentially affected.