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Terminated

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.

FDA Recall Z-0156-2013 · Posted 2012-10-25

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeNEP
Date Initiated2012-10-03
Date Terminated2013-02-15

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.

Firm 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.

Root Cause

Packaging process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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