FDA Device recall Z-0420-2022
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- FDA Device
- Class II
- terminated
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM by Abbott, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0420-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-16 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott |
| Distribution | US |
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Reason
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.
Identifiers
| code_info | Model 407831, Lot 7748246, GTIN: 15414734008805 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2022%22
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