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.
This recall has been terminated (originally issued October 25, 2012).
- Company
- Baxa Corporation
- Recall Initiated
- October 3, 2012
- Posted
- October 25, 2012
- Terminated
- February 15, 2013
- Recall Number
- Z-0156-2013
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
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
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.
Lot / Code Info
Repeater Pump model #s 095, 099, and 099R.
Root Cause
Packaging process control
Action Taken
Baxa Corporation sent a "REPEATER PUMP PRODUCT NOTICE" to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received a CD containing a copy of the correct Operator Mannual, 5300-0754. Contact Technical Support at 800-678-2292 for questions regarding this notice.