Ultimum HEMOSTASIS INTRODUCER 5f 1 — Class II medical device recall Z-0420-2022
Terminated recall by Abbott, reported 2022-01-05, distributed nationwide. As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured wi
| Recall number | Z-0420-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Plymouth, MN, United States |
| Recall initiated | 2021-11-16 |
| Classified | 2021-12-27 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 15414734008805 |
| Lot numbers | 7748246 |
| Model numbers | 407831 |
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Reason for recall
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
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-0420-2022. 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.