Z-0156-2013Class II

Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution...

Name: Z-0156-2013 Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution...
Creator: Baxa Corporation
Published: 2012-10-03
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2012-10-03 / Terminated / root cause: packaging

FDA source

Baxa Corporation began a recall of Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid... on 2012-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0156-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-03
Posted: 2012-10-25
Terminated: 2013-02-15
Recalling firm: Baxter Corporation Englewood
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.
Product code: NEP System/Device, Pharmacy Compounding
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.
Root cause tag: packaging
FDA 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.
Product codes and lots: Repeater Pump model #s 095, 099, and 099R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0156-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0156-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)