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

Recall

73238

Class 2

Z-1179-2016

2016-02-15

Terminated

United States

2016-10-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143611

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.

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.