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Terminated

SmartSite Extension Set, Model No. 20029E, intravascular administration set.

FDA Recall Z-1459-2014 · Posted 2014-04-16

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-03-19
Date Terminated2015-06-06
Product Quantity7,700 units

Reason for Recall

Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

Firm Action

CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed 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 the Alaris System are instructed to contact Technical Support at (888) 812-3299.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSY · 1996-04-04

Official Source

View FDA Recall →

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

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