—#121571

Product

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K944320
Affected lot / code info: Lot Numbers 13015883 and 13025342.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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. .

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI

Timeline

Recall initiated: 2013-08-30
Posted by FDA: 2013-09-26
Terminated: 2014-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.