Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 22, 2017
Plum 360 Infusion System, List number 30010.
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Icu Medical Inc recalled Plum 360 Infusion System, List number 30010. - a moderate-severity action.
Plum 360 Infusion System, List number 30010. was recalled by Icu Medical Inc in November 22, 2017. Reason: (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting f…. Check the official notice for the remedy. Verify recall #Z-0101-2018 with the FDA Devices before acting.
The recall
Icu Medical Inc issued this moderate-severity FDA Devices recall-(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting f….
- Moderate
- severity level
- 21K units
- affected scope
- Class II
- classification
- November 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0101-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0101-2018) was formally reported on November 22, 2017, with the manufacturer initiating the action on October 30, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Icu Medical Inc is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 21,461 devices.
The documented reason for this recall is: (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the b… Distribution data in the federal record shows the product reached: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.. 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 - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 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.
Affected scope
21,461 devices
Related Recalls
6
0 from same agency
Product description
Plum 360 Infusion System, List number 30010.
Reason for recall
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0101-2018 |
| Date reported | November 22, 2017 |
| Date initiated | October 30, 2017 |
| Recalling firm | Icu Medical Inc |
| Firm location | Lake Forest, IL |
| Affected scope | 21,461 devices |
| Distribution | Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made. |
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.
- Check the recall number (Z-0101-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Plum 360 Infusion System, List number 30010.. Recalled by Icu Medical Inc. Units affected: 21,461 devices.
Why was this product recalled? ▼
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2017. Severity: Moderate. Recall number: Z-0101-2018.
Where was the recalled product distributed? ▼
Distribution: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0101-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 November 22, 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.