Z-0051-2017Class II

MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate...

Name: Z-0051-2017 MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate...
Creator: Argon Medical Devices, Inc
Published: 2016-09-08
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2016-09-08 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2016-09-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0051-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-08
Posted: 2016-10-07
Terminated: 2017-06-07
Recalling firm: Argon Medical Devices, Inc
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact [email protected].
Quantity in commerce: 200 units
Distribution: Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Product codes and lots: 11149662, 11151447, 11151617, and 11149822.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0051-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-06

Product code DYB

K071574Class IIStiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. / cleared 2007-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)