ModerateClass IITerminated

FDA Devices recall · Reported February 27, 2013

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0832-2013.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observe…

Recall #: Z-0832-2013
Affected scope: 5,050 units
Initiated: December 20, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Carefusion 303 Inc recalled CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood… - a moderate-severity action.

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood… was recalled by Carefusion 303 Inc in February 27, 2013. Reason: CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the con…. Check the official notice for the remedy. Verify recall #Z-0832-2013 with the FDA Devices before acting.

The recall

Carefusion 303 Inc issued this moderate-severity FDA Devices recall-CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the con….

Moderate
severity level: 5K units
affected scope: Class II
classification: February 27, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0832-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

Reason for recall

CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0832-2013
Date reported	February 27, 2013
Date initiated	December 20, 2012
Recalling firm	Carefusion 303 Inc
Firm location	San Diego, CA
Affected scope	5,050 units
Distribution	Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

5,050 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0832-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.. Recalled by Carefusion 303 Inc. Units affected: 5,050 units.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0832-2013.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 27, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026