CareFusion 303, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1883-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SmartSite Add-On Bag Access Device, Model No. 10013365

Product Classification:

Class II

Date Initiated: November 17, 2016

Date Posted: May 3, 2017

Recall Number: Z-1883-2017

Event ID: 75013

Reason for Recall:

CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.

Status: Terminated

Product Quantity: 384,923 units

Code Information:

15055146 15055702 15056299 15056618 15065645 15075740 15076166 15076167 15076664 15076729 15077085 15085031 15085156 15086107 15095014 15095411 15106928 15116928 15125952 15126069 15127413 16015324 16015325 16015607 16025824 16025948 16027008 16035527 16036131

Distribution Pattern:

US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated