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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95874

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

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Event summary

Timeline bucket
December 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
B. Braun Medical, Inc.

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

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159

Z-1021-2025
Recall number
Z-1021-2025
Initiated
December 04, 2024
Classification
Class II
Status
Ongoing
Recalling firm
B. Braun Medical, Inc.
Quantity
1090 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

Code information

UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572

Distribution pattern

US Nationwide distribution in the states of MO, OK.