Plum A+ Hyperbaric Single Channel Infusion Pumps — Class II medical device recall Z-0626-2013
Terminated recall by Hospira Inc., reported 2013-01-09, distributed in PR. The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can le
| Recall number | Z-0626-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-12-07 |
| Classified | 2012-12-31 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2016-11-14 |
| Distributed | PR |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, DK, ES, FI, FR, GB, GR, HK, ID, IE, IL, IT, JO, KW, LB, MX, MY, NL, NZ, OM, PE, PH, PK, PL, PT, SA, SE, SG, SI, TR, TW, VN |
| Quantity | 180 units |
| Reason classes | device malfunction |
Product
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Reason for recall
The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
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-0626-2013. 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.