Reported Nov 22, 2017 · Terminated
Plum 360 Infusion System, List number 30010.
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
Plum 360 Infusion SystemList number 30010
- Lot codes and dates
- All devices with software v15.10.00.010
- Amount recalled
- 21,461 devices
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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