SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
FDA Recall Z-0221-2016 · Posted 2015-11-05
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Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2015-10-09
Date Terminated2017-03-02
Product Quantity21,000 units
Reason for Recall
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Firm Action
An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email [email protected]. Customers with technical questions regarding technical questions are instructed to contact Technical Support at (888) 812-3229.
Root Cause
Process control
Distribution Pattern
Distributed US (nationwide) and in Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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