Z-0171-2020 Class II Terminated
FDA device recall Z-0171-2020 was initiated by ICU Medical Inc on Aug 1, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 27, 2021). Affected quantity: 47,152 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2019
- Initiation Date
- Aug 1, 2018
- Termination Date
- Apr 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,152 devices
Product Description
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Reason for Recall
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.
Distribution Pattern
US nationwide distribution, and Canada
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0171-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026