Plum 360 Infusion System With MedNet/ Smart Card Plug recall: Software Issue
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Why was Plum 360 Infusion System With MedNet/ Smart Card Plug 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
- Recalling firm
- ICU Medical Inc
- Quantity
- 47,152 devices
- Distribution
- US nationwide distribution, and Canada
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)