Lower risk Medical device recall · FDA · Published June 19, 2020

Argon Medical Devices: ClosureFast Micro Introducer Sheath Set Recall Due to Expiration

Argon Medical Devices recalls ClosureFast Micro Introducer Sheath Set (REF MIS-7F1: 7Fr/Ch 2.3mm x11 cm) due to sterile sheaths with different expiration dates. This affects medical devices used in vein/artery procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2806-2020Medical device Argon Medical Devices ›

Lower-risk recall

Sterile introducer sheath set manufactured under one lot with different expiration dates.

Take action

Contact the company

Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002

✎ GovInfoNow plain-language explainer

Argon Medical Devices is recalling a specific sterile micro introducer sheath set used in medical procedures because it was manufactured with different expiration dates in one production lot. This could lead to improper use if the sheath expires before the procedure. Read more at govinfonow.com/recall/64942-argon-medical-devices-closurefast-micro-introducer-sheath-set-recall-due.

Source Summary by GovInfoNow · govinfonow.com/recall/64942-argon-medical-devices-closurefast-micro-introducer-sheath-set-recall-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2806-2020

Cite this page

“Argon Medical Devices: ClosureFast Micro Introducer Sheath Set Recall Due to Expiration.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64942-argon-medical-devices-closurefast-micro-introducer-sheath-set-recall-due. Based on FDA recall #Z-2806-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2806-2020%22&limit=1).

The FDA announced on June 19, 2020, that Argon Medical Devices, Inc. is recalling ClosureFast Micro Introducer Sheath Sets because sterile units were manufactured under one lot with different expiration dates. The agency classified the recall as Class II.

How to tell if you have it

Brand: Argon Medical Devices
Product: ClosureFast Micro Introducer Sheath Set
REF: MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY
Lot code: 11295042

The hazard

The recall addresses sterile introducer sheath sets manufactured under a single lot that have varying expiration dates.

Context

GovInfoNow's records show Argon Medical Devices, Inc. has had 15 other recalls on record since October 16, 2018. Other recent recalls of similar products include Cook Medical Blue Rhino Tracheostomy Introducer Set (March 5, 2026), Cook Medical Blue Rhino G2 Tracheostomy Introducer Set (March 5, 2026), and Cook Medical Wayne Pneumothorax Set (March 5, 2026).

How to tell if you have this one

Check for the product name 'ClosureFast Micro Introducer Sheath Set', reference number MIS-7F11, and the lot number 11295042. The sheath is sterile, for medical use only, and measures 7Fr/Ch (2.3mm)x11 cm.

Brand
Argon Medical Devices
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Expiration Date
Verify the expiration date on the sheath packaging to ensure it is current for medical use.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution including in the state of MS.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Jun 19, 2020Firm started the recall
Aug 14, 2020FDA classified it Class II
Aug 26, 2020Published in FDA’s Enforcement Report
Apr 12, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Argon Medical Devices recalls

Link to this recall

<a href="https://govinfonow.com/recall/64942-argon-medical-devices-closurefast-micro-introducer-sheath-set-recall-due">Argon Medical Devices: ClosureFast Micro Introducer Sheath Set Recall Due to Expiration (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2806-2020 (June 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2806-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.