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Recall Observatory FDA recall evidence

Device product

Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Z-0405-2017

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-0405-2017

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: 777400, 777600, 777700, 777800, 778400, 778600, 778700, 778800, 786400, 786600, 786700,786800, 787400, 787600, 787700, 787800, 788400, 788600, 788700 and 788800.

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.