SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
FDA Recall Z-2285-2013 · Posted 2013-09-26
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Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-08-30
Date Terminated2014-04-16
Product Quantity15860 units
Reason for Recall
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
Firm Action
A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on 8/30/13 to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. .
Root Cause
Process design
Distribution Pattern
Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
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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