MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo… — Class II medical device recall Z-0051-2017
Terminated recall by Argon Medical Devices, Inc, reported 2016-10-12, distributed in MS, TN. The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the di
| Recall number | Z-0051-2017 |
|---|---|
| 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 | 2016-09-08 |
| Classified | 2016-10-06 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-06-07 |
| Distributed | MS, TN |
| Countries outside the US | CA |
| Quantity | 200 units |
Product
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason for recall
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
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-0051-2017. 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.