CLASS I ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report
Replacement Battery List Number SUB0000864, found recalled
ICU Medical is recalling Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1565-2023
- FDA event ID
- 91874
- Recalling firm
- ICU Medical, Lake Forest, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 16 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 16 May 2023 | Classified by FDA | +55 days |
| 24 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Where it was distributed
worldwide
Questions about this recall
Is Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List recalled?
Yes. ICU Medical recalled Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List on 22 Mar 2023. The recall is Class I and its status is Ongoing. Recall number Z-1565-2023.
Why was it recalled?
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Which lots are affected?
All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Where was it sold?
worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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