CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Plum A+ Hyperbaric Infusion Pump recalled by Hospira
Hospira is recalling Plum A+ Hyperbaric Infusion Pump, distributed nationwide in the US. The recall was initiated on 6 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2722-2016
- FDA event ID
- 64261
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2013
- FDA classified
- 6 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 6 Feb 2013 | Recall initiated by company | |
| 6 Sep 2016 | Classified by FDA | +1308 days |
| 14 Sep 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Where it was distributed
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
Questions about this recall
Why was it recalled?
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Which lots are affected?
List Number 11005. Serial numbers: 16792201, 16792202, 16792205, 16792206, 16792208, 16792209, 16792210, 16792211, 16792213, 16792216, 16792217, 16792219, 16792220, 16792222, 16792223, 16792224, 16792225, 16792226, 16792227, 16792228, 16792230, 16792232, 16792233, 16792234, 16792235, 16792236, 16792238, 16792239, 16792240, 16792241, 16792242, 16792244, 16792245, 16792246, 16792248, 16792249, 16792250, 16792251, 16792252, 16792253, 16792254, 16792255, 16792256, 16792257, 16792258, 16792259, 16792260, 16792261, 16792263, 16792264, 16792265, 16792266, 16792268, 16792269, 16792271, 16792272, 16792273, 18807402, 18807405, 18807406, 18807407, 18807408, 18807409, 18807410, 18807413, 18807414, 18807417, 18807418, 18807420, 18807421, 18807423, 18807427, 18807428, 18807429, 18807430, 18807431, 18807432, 18807433, 18807434, 18807439, 18807443, 18807444, 18807446, 18807449, 18807452, 18807453, 18807455, 18807456, 18807459, 18807463, 18807466, 18807472, 18807474, 18807478, 18807484, 18807485, 18807486, 18807490, 18807491, 18807494, 18807496, 18807499, 18807500, 18807501, 18807506, 18807509, 18807510, 18807511, 18807513, 18807514, 18807518, 18807523, 18807524, 18807529, 18807535, 18807536, 18807539, 18807540, 18807541, 18807542, 18807543, 18807545, 18807546, 18807556, 18807557, 18807568, 18807574, 18807575, 18807576, 18807578, 18807581, 18807584, 18807585, 18807586, 18807588, 18807589, 18807590, 18807591, 18807596, 18807597, 18807598, 18807599, 18807600, 18807601, 18807602, 18807604, 18807605, 18807607, 18807608, 18807609, 18807610, 18807611, 18807612, 18807613, 18807614, 18807617, 18807618, 18807619, 18807620, 18807623, 18807625, 18807626, 18807627, 18807628, 18807630, 18807631, 18807632, 18807633, 18807634, 18807636, 18807637, 18807639, 18807640, 18807695, 18807696, 18807697, 18807698, 18807699, 18807700.
Where was it sold?
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 64261| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Plum A+ Infusion Pump recalled by Hospira | Hospira | Device Malfunction | Nationwide | |
| CLASS II | Plum A+3 Infusion Pump System recalled by Hospira | Hospira | Device Malfunction | Nationwide |
More recalls from Hospira
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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Infusion Pumps recalls
All 549| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |