Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that… — Class II medical device recall Z-0481-2013
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-0481-2013 |
|---|---|
| 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+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
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
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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.