The Recall Desk
HighFDA (Devices)·Z-0832-2013·Announced 2013-02-27

CareFusion Recalls SmartSite Gravity Blood Sets Due to Connection Separation

CareFusion is recalling 5,050 units of SmartSite Gravity Blood Sets because the drip chamber and tubing may separate, potentially delaying treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect could cause a delay in treatment, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

CareFusion 303 Inc is recalling 5,050 units of the SmartSite Gravity Blood Set, Model 42082E. These medical devices are used to administer blood and blood products through a needle or catheter inserted into a patient's artery or vein. The recall is limited to Lot number 12055225.

The recall is being conducted because of a potential for separation at the connection between the drip chamber and the tubing. This separation may be observed during priming or during use. If the separation occurs, it could cause a delay in treatment.

The affected products were distributed nationwide, including in the states of Alaska, California, Colorado, Illinois, Missouri, Nevada, New York, Texas, and Utah. Healthcare facilities and consumers should stop using the affected blood sets and contact CareFusion for further instructions.

The recalled product

Product
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.
Manufacturer
Carefusion 303 Inc
Category
Medical Device — Blood Administration
Hazard
Affected units
5,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number 12055225

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Related recalls

Same manufacturer · Carefusion 303 Inc

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Same hazard · connection separation

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