CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report
Plum 360 Infusion System recalled by ICU Medical
ICU Medical is recalling Plum 360 Infusion System, distributed nationwide in the US. The recall was initiated on 15 Jun 2017 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-3031-2017
- FDA event ID
- 77624
- Recalling firm
- ICU Medical, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2017
- FDA classified
- 14 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Jun 2017 | Recall initiated by company | |
| 14 Aug 2017 | Classified by FDA | +60 days |
| 23 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
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 360 Infusion System
Where it was distributed
Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMarylandMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Is Plum 360 Infusion System recalled?
Yes. ICU Medical recalled Plum 360 Infusion System on 15 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3031-2017.
Why was it recalled?
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Which lots are affected?
Model No. 30010
Where was it sold?
Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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