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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89123

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 16, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

Z-0420-2022
Recall number
Z-0420-2022
Initiated
November 16, 2021
Classification
Class II
Status
Terminated
Recalling firm
Abbott
Quantity
10 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model 407831, Lot 7748246, GTIN: 15414734008805

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.