Argon Medical Devices, Inc recalls MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a cath…

Recall date

September 8, 2016

Source

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

Recall number

Z-0051-2017

FDA classification

Class II

Brand / firm

Argon Medical Devices, Inc

Sold / distributed

Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.

Why it was recalled

The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath

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

What was recalled

MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.