Exact FDA event identifier

Event 70260

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

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Event summary

Timeline bucket: January 13, 2015
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

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

Z-1053-2015

Recall number: Z-1053-2015
Initiated: January 13, 2015
Classification: Class II
Status: Terminated
Recalling firm: CareFusion 303, Inc.
Quantity: 7,440 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

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

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

Code information

Lot No. 12056016, 12057027, and 12107105.

Distribution pattern

Nationwide Distribution