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Recall Observatory FDA recall evidence

Device product

Plum 360 Infusion System

Z-3031-2017

June 15, 2017

Class II

Product summary

Firm
ICU Medical Inc
Event
Event 77624
Status
Terminated
Classification
Class II
Quantity
68,559 units
Official record key
device-enforcement:Z-3031-2017

Official wording

Reason: 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.

Code information: Model No. 30010

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.