Smiths Medical Asd Inc recalls Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED…

Recall date

May 4, 2015

Source

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

Recall number

Z-1730-2015

FDA classification

Class II

Brand / firm

Smiths Medical Asd Inc

Sold / distributed

Distributed to the states of KY, MN, NJ, UT, & WI.

Why it was recalled

Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

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

What was recalled

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.