Fast-Cath Trio HEMOSTASIS INTRODUCER — Class II medical device recall Z-0783-2020
Terminated recall by Abbott Medical, reported 2020-01-15, distributed nationwide. Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected
| Recall number | Z-0783-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Plymouth, MN, United States |
| Recall initiated | 2019-12-09 |
| Classified | 2020-01-07 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, MY, PY |
| Quantity | 814 devices |
| UPC / GTIN / UDI-DI | 15414734203903 |
| Lot numbers | 7133555 |
| Model numbers | 406303 |
Product
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Reason for recall
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
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-0783-2020. 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.