Plum 360 Infusion System With MedNet/ Smart Card Plug And… recallZ-0171-2020 · ICU Medical Inc · initiated Aug 1, 2018
Class II Terminated All recalls posted in October 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
FDA root cause category: Software change control
What the company is doing
On 8/1/2018 a "Urgent Medical Device Correction" letter was mailed to consignees via traceable mailing. The medical device correction letter informed consignees of the following: 1. To reduce the likelihood of the issue occurring at the bedside, you can consider not utilizing the option to "Force Pump to Accept Drug Library During Power Down" when finalizing the CDL with MedNet. In doing so, when powering down the infuser the clinician will have the option to install the CDL or not, based on the clinical situation. 2. ICU Medical will release a software update to correct the issue and will contact you when the update is available. 3. . Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular 4.Please inform potential users in your organization of this notification, complete the attached response form and return it to the fax number (1-888-628-6849 or e-mail address ([email protected]) on the form, even if you do not have the affected product. 5. For further inquiries, please contact ICU Medical using the information provided below: Global Complaint Management - 1-844-654-7780 or [email protected] Technical Support Center - 1-800-241-4002, option 4 or [email protected]
Recall details
- Recall number
- Z-0171-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 1, 2018
- Posted by the FDA
- Oct 22, 2019
- Recalling firm
- ICU Medical Inc
- Quantity
- 47,152 devices
- Product code
- FRN
- FDA submissions
- K161469
- Distribution
- US nationwide distribution, and Canada
Product description
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Code information (models, lots, serial numbers)
All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL
Other devices under the same FDA submission
2 devices cleared under K161469 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Plum 360 300100414Icu Medical, Inc. · Pump, infusion10 reports
- Plum 360 300100413Icu Medical, Inc. · Pump, infusion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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