The Recall Desk
ModerateFDA (Devices)·Z-0404-2017·Announced 2016-11-23

Bard Inlay Ureteral Stent Recalled for Labeling Update

C.R. Bard is recalling 75,089 Bard Inlay 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 for a labeling error (missing warning) rather than a physical defect or contamination, which aligns with the rubric for minor labeling errors.

Plain-English summary

C.R. Bard, Inc. is recalling 75,089 units of Bard Inlay Ureteral Stents with Suture. The recall is limited to a labeling correction where a statement was added to the Warnings/Precautions section. The new text requests end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

The affected product codes are 776400, 776600, 776700, and 776800. The recall is distributed nationwide in the United States. This action is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Manufacturer
C.R. Bard, Inc.
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 (4)

  • Product Codes: 776400
  • 776600
  • 776700
  • and 776800.

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.

See all 4 products in this recall →