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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76439

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

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Event summary

Timeline bucket
February 20, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

Z-1464-2017
Recall number
Z-1464-2017
Initiated
February 20, 2017
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
1,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

Code information

Lot No. 16016790

Distribution pattern

US Distribution including MA and MD