Protek Solo Venous Dilator Set: dilator — Class II medical device recall Z-1486-2021
Terminated recall by Cardiac Assist, Inc, reported 2021-05-05, distributed nationwide. On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021,
| Recall number | Z-1486-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2021-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 13 kits |
| UPC / GTIN / UDI-DI | 00814112020463, 00814112020517, 00814112020708 |
| Serial numbers | 00145202, 00145204, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567, 00871587, 285586 |
| Model numbers | 5100-1422, 5740-2417, 5840-2415LS, 5840-2417LS |
Product
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)
Reason for recall
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
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-1486-2021. 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.