CLASS II Device recall · Reported 5 Jan 2022 · FDA Enforcement Report
Ultimum Hemostasis Introducer 5f recalled by Abbott
Abbott is recalling Ultimum Hemostasis Introducer 5f, distributed nationwide in the US. The recall was initiated on 16 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0420-2022
- FDA event ID
- 89123
- Recalling firm
- Abbott, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2021
- FDA classified
- 27 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 16 Nov 2021 | Recall initiated by company | |
| 27 Dec 2021 | Classified by FDA | +41 days |
| 5 Jan 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Where it was distributed
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Questions about this recall
Why was it 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.
Which lots are affected?
Model 407831, Lot 7748246, GTIN: 15414734008805
Where was it sold?
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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