Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95586

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

Open FDA event record

Event summary

Timeline bucket
October 22, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
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

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197

Z-0482-2025
Recall number
Z-0482-2025
Initiated
October 22, 2024
Classification
Class I
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
3840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Code information

All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx

Distribution pattern

Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.