Recall Z-0156-2013— Baxa Corporation

Class II FDA medical device recall by Baxa Corporation, initiated 2012-10-03, terminated 2013-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.. Reason: The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use..

Recalling firm

Baxa Corporation

Classification

Class II

Status

Terminated

Initiated

2012-10-03

Terminated

2013-02-15

Firm location

Englewood, CO, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.