Repeater Pump — Class II medical device recall Z-0156-2013
Terminated recall by Baxa Corporation, reported 2012-10-31, distributed nationwide. The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the
| Recall number | Z-0156-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxa Corporation, Englewood, CO, United States |
| Recall initiated | 2012-10-03 |
| Classified | 2012-10-25 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, GB, JP, MX, MY, PA, TW, VE |
| Model numbers | 095, 099, 099R |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0156-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.