FDA Device recall Z-2806-2020
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of ClosureFast Micro Introducer Sheath Set, REF MIS-7F11 by Argon Medical Devices, citing sterile introducer sheath set manufactured under one lot with different expiration dates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2806-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-19 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
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.
Reason
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Identifiers
| code_info | LOT 11295042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2806-2020%22
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