C.R. Bard, Inc. recalls Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureter…

Recall date

October 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0405-2017

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

U.S. Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.