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U.S. Department of Health and Human Services

Class 2 Device Recall Repeater Pump

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 Class 2 Recall
Repeater Pump
see related information
Date Posted October 25, 2012
Recall Status1 Terminated on February 15, 2013
Recall Number Z-0156-2013
Recall Event ID 63379
Product Classification System/Device, Pharmacy Compounding - Product Code NEP
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.
Code Information Repeater Pump model #s 095, 099, and 099R.
Recalling Firm/
Manufacturer
Baxa Corporation
14445 Grasslands Dr
Englewood, Colorado 80112-7062
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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