Z-0420-2022Class II

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

Name: Z-0420-2022 Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Creator: Abbott
Published: 2021-11-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-11-16 / Terminated / root cause: manufacturing process

FDA source

Abbott began a recall of Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM on 2021-11-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0420-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-16
Posted: 2021-12-27
Terminated: 2024-06-18
Recalling firm: Abbott Medical
Product: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 10 units
Distribution: Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Product codes and lots: Model 407831, Lot 7748246, GTIN: 15414734008805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0420-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0420-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-05	2021-12-27

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)