ULTIMUM recallZ-0420-2022 · Abbott · initiated Nov 16, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices.
Recall details
- Recall number
- Z-0420-2022
- Status
- Terminated
- Initiated by the company
- Nov 16, 2021
- Recalling firm
- Abbott
- Quantity
- 10 units
- Product code
- DYB
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Product description
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Code information (models, lots, serial numbers)
Model 407831, Lot 7748246, GTIN: 15414734008805
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ULTIMUM™ 407831St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall40 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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