Z-0156-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2012
- Initiation Date
- October 3, 2012
- Termination Date
- February 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.
Code Information
Repeater Pump model #s 095, 099, and 099R.