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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96323

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 18, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
CareFusion 303, 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

2 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 2

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Z-1304-2025
Recall number
Z-1304-2025
Initiated
February 18, 2025
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
Unavailable

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

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

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Code information

Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Distribution pattern

US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None

device · product 2 of 2

BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software

Z-1305-2025
Recall number
Z-1305-2025
Initiated
February 18, 2025
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
Unavailable

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

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

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Code information

Software: v1.7.2/UDI: 10885403510472

Distribution pattern

US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None