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Recall Observatory FDA recall evidence

Device product

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

Z-2285-2013

August 30, 2013

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 66151
Status
Terminated
Classification
Class II
Quantity
15860 units
Official record key
device-enforcement:Z-2285-2013

Official wording

Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

Code information: Lot Numbers 13015883 and 13025342.

Distribution pattern: Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.