Severity
Moderate
FDA Devices recall · Reported April 5, 2017
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump re…
Hospira Inc., A Pfizer Company recalled Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of deliverin… - a moderate-severity action.
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of deliverin… was recalled by Hospira Inc., A Pfizer Company in April 5, 2017. Reason: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show…. Check the official notice for the remedy. Verify recall #Z-1682-2017 with the FDA Devices before acting.
The recall
Hospira Inc., A Pfizer Company issued this moderate-severity FDA Devices recall-Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1682-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1682-2017) was formally reported on April 5, 2017, with the manufacturer initiating the action on December 30, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc., A Pfizer Company is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 62,847 units.
The documented reason for this recall is: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy … Distribution data in the federal record shows the product reached: Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
62,847 units
Related Recalls
6
3 from same agency
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1682-2017 |
| Date reported | April 5, 2017 |
| Date initiated | December 30, 2016 |
| Recalling firm | Hospira Inc., A Pfizer Company |
| Firm location | Lake Forest, IL |
| Affected scope | 62,847 units |
| Distribution | Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 5, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.