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Terminated

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

FDA Recall Z-1883-2017 · Posted None

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2016-11-17
Date Terminated2018-10-29
Product Quantity384,923 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

US Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970485SMARTSITE ACCESS PINIvac Medical Systems · 1997-04-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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