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Recall Observatory FDA recall evidence

Device product

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

Z-0404-2017

October 13, 2016

Class II

Product summary

Firm
C.R. Bard, Inc.
Event
Event 75492
Status
Terminated
Classification
Class II
Quantity
75,089 units
Official record key
device-enforcement:Z-0404-2017

Official wording

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.

Code information: Product Codes: 776400, 776600, 776700, and 776800.

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.