Z-1883-2017Class II

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

Name: Z-1883-2017 SmartSite Add-On Bag Access Device, Model No. 10013365
Creator: CareFusion 303, Inc.
Published: 2016-11-17
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-11-17 / Terminated

FDA source

CareFusion 303, Inc. began a recall of SmartSite Add-On Bag Access Device, Model No. 10013365 on 2016-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1883-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-17
Posted: 2017-04-27
Terminated: 2018-10-29
Recalling firm: CareFusion 303, Inc
Product: SmartSite Add-On Bag Access Device, Model No. 10013365
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Other
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy at (888) 812-3266 or by email at [email protected]. Customers are instructed to complete and return the enclosed mandatory customer response card.
Quantity in commerce: 384,923 units
Distribution: US Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1883-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1883-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

Product code FPA

K970485Class IISmartsite Access PinIvac Medical Systems / cleared 1997-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)