CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report
ClosureFast Micro Introducer Sheath Set recalled
Argon Medical Devices is recalling ClosureFast Micro Introducer Sheath Set, distributed nationwide in the US. The recall was initiated on 19 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2806-2020
- FDA event ID
- 86036
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2020
- FDA classified
- 14 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 19 Jun 2020 | Recall initiated by company | |
| 14 Aug 2020 | Classified by FDA | +56 days |
| 26 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the state of MS.
Questions about this recall
Why was it recalled?
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Which lots are affected?
LOT 11295042
Where was it sold?
US Nationwide distribution including in the state of MS.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Argon Medical Devices
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS II | L-Cath Midline S/L Catheter (3F) recalled by Argon Medical Devices | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS I | Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | T-Lok Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | One-Piece Introducer Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |