ClosureFast Micro Introducer Sheath Set 7Fr/Ch — Class II medical device recall Z-1029-2016
Terminated recall by Argon Medical Devices, Inc, reported 2016-03-09, distributed in IL. The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the si
| Recall number | Z-1029-2016 |
|---|---|
| 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 | 2016-02-17 |
| Classified | 2016-03-01 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-03-08 |
| Distributed | IL |
| Quantity | 2,000 units |
| Lot numbers | 11126021, 1125585 |
| Model numbers | IS-7F11, MIS-F707 |
Product
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reason for recall
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
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-1029-2016. 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.