Z-2722-2016 Class II Terminated
FDA device recall Z-2722-2016 was initiated by Hospira Inc. on Feb 6, 2013 and is designated Class II. 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. The recall status is terminated (terminated Nov 14, 2016). Affected quantity: 357,778 total.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2016
- Initiation Date
- Feb 6, 2013
- Termination Date
- Nov 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 357,778 total
Product Description
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.
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.
Distribution Pattern
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2722-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026