Reported Oct 31, 2012 · Terminated
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital…
Baxa Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxa Corporation · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- 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.
- Lot codes and dates
Repeater Pump model #s 095099and 099R
- Amount recalled
- N/A
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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