ClosureFast Micro Introducer Sheath Set — Class II medical device recall Z-2806-2020
Terminated recall by Argon Medical Devices, Inc, reported 2020-08-26, distributed nationwide. Sterile introducer sheath set manufactured under one lot with different expiration dates.
| Recall number | Z-2806-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2020-06-19 |
| Classified | 2020-08-14 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2023-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,000 units |
| Reason classes | sterility |
| Lot numbers | 11295042 |
| Model numbers | MIS-7F11 |
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 for recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2806-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.