Recalls / —

—#143611

Product

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K944320

Affected lot / code info

Lot No. 13085603

Why it was recalled

CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

Root cause (FDA determination)

Other

Action the firm took

A customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact Customer Advocacy at (888)812-3266, customerfeedback@carefusion.com, 24 hrs/day, 7 days/wk. Customers are instructed to complete and return the enclosed mandatory customer response card to acknowledge the receipt of the customer communication.

Recalling firm

Firm

CareFusion 303, Inc.

Address

10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern

Michigan

Timeline

Recall initiated

2016-02-15

Terminated

2016-10-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #143611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.