The Recall Desk
HighFDA (Devices)·Z-1464-2017·Announced 2017-03-22

CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports

CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.

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 with a structural defect (separation/leakage) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305. The recall involves 1,200 units distributed in the United States, including Massachusetts and Maryland.

The recall is being conducted due to reports of separation and/or leakages between the Y-connector and the tubing. The affected products are identified by Lot No. 16016790.

Consumers and healthcare facilities should stop using the affected products and contact CareFusion for further instructions.

The recalled product

Product
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion/IV Equipment
Hazard
Affected units
1,200

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 No. 16016790

Distribution

Distributed in 2 states:

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