FDA-Device2016-10-12Class II

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.

Argon Medical Devices, Inc
Hazard

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

Sold states
Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Affected count
200 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0051-2017

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