Recall Z-0156-2013 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
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
| Date | Oct 25, 2012 (initiated Oct 3, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.