Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83480

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 01, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ICU Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

Z-0171-2020
Recall number
Z-0171-2020
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical Inc
Quantity
47,152 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software malfunction

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

US nationwide distribution, and Canada

Field note

Send feedback

We'll only use this to respond to your feedback.