Fast-Cath Hemostasis Introducer — Class II medical device recall Z-0789-2020
Terminated recall by Abbott Medical, reported 2020-01-15, distributed nationwide. Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the e
| Recall number | Z-0789-2020 |
|---|---|
| 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 | 2020-01-08 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CZ |
| Quantity | 380 devices |
| UPC / GTIN / UDI-DI | 15414734014219 |
| Lot numbers | 6917183, 6950628, 7099144 |
| Model numbers | 406143 |
Product
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Reason for recall
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F 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-0789-2020. 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.