Z-0101-2018 Class II Terminated
FDA device recall Z-0101-2018 was initiated by ICU Medical Inc on October 30, 2017 and is designated Class II. 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 re… The recall status is terminated (terminated August 28, 2019). Affected quantity: 21,461 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2017
- Initiation Date
- October 30, 2017
- Termination Date
- August 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,461 devices
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.
Distribution Pattern
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
Code Information
All devices with software v15.10.00.010