Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet… — Class II medical device recall Z-0482-2013
Terminated recall by Hospira Inc., reported 2012-12-19, distributed nationwide. The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not f
| Recall number | Z-0482-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-10-26 |
| Classified | 2012-12-07 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2016-11-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, BR, CA, CH, CL, CO, DK, ES, FR, GB, GR, HK, ID, IE, IL, IT, JO, JP, KR, KW, LB, MX, MY, NL, NZ, OM, PH, PK, PL, PT, SA, SG, TR, TW, VN, ZA |
Product
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Reason for recall
The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
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-0482-2013. 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.