Skater Introducer Set 6F x 18cm — Class II medical device recall Z-2109-2020
Terminated recall by Argon Medical Devices, Inc, reported 2020-06-03. Tungsten coils of the guidewire included in the introducer kit were detaching.
| Recall number | Z-2109-2020 |
|---|---|
| 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 | 2020-04-26 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-12-16 |
| Countries outside the US | CN, TW |
| Quantity | 15,795 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00886333005000, 00886333005079 |
| Lot numbers | 11248583, 11252843, 11253443, 11254942, 11258778, 11260512, 11262264, 11263199, 11266592, 11267865, 11268009, 11271397, 11277295, 11277305, 11280359, 11284776, 11285976, 11287825, 11287826, 11288772, 11290387, 11293349, 651506300, 655506300 |
Product
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
Reason for recall
Tungsten coils of the guidewire included in the introducer kit were detaching.
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-2109-2020. 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.