Z-2806-2020Class II

ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY -

Name: Z-2806-2020 ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY -
Creator: Argon Medical Devices, Inc
Published: 2020-06-19
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2020-06-19 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone... on 2020-06-19. FDA classified it as Class II and gives the reason as "Sterile introducer sheath set manufactured under one lot with different expiration dates". 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-2806-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-19
Posted: 2020-08-14
Terminated: 2023-04-12
Recalling firm: Argon Medical Devices, Inc
Product: ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Sterile introducer sheath set manufactured under one lot with different expiration dates.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm communicated to Medtronic the recommendation of a voluntary recall. The product is an OEM product manufactured specifically for Medtronic, and Argon does not have visibility to the end-use customers receiving these products. On 06/19/2020 the OEM customer was notified about the recall via telephone call and had requested to return all unused units.
Quantity in commerce: 1000 units
Distribution: US Nationwide distribution including in the state of MS.
Product codes and lots: LOT 11295042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2806-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2806-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14

Product code DRE

K780126Class IIDilator, Vessel & Introducer, SheathArgon Medical Corp. / cleared 1978-03-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)