Replacement Battery List Number SUB0000864, found in Plum… recallZ-1565-2023 · ICU Medical Inc · initiated Mar 22, 2023
Class I Open, Classified All recalls posted in May 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals. 1. Identify all affected batteries in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected].
Recall details
- Recall number
- Z-1565-2023
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Mar 22, 2023
- Posted by the FDA
- May 16, 2023
- Recalling firm
- ICU Medical Inc
- Quantity
- 28656 units
- Product code
- FRN
- FDA submissions
- K141789, K161469
- Distribution
- worldwide
Product description
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Code information (models, lots, serial numbers)
All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Other devices under the same FDA submission
35 devices cleared under K141789, K161469 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Plum 1468728ICU Medical, Inc. · Set, administration, intravascular1 recall2 deaths482 reports
- Plum 1425628ICU Medical, Inc. · Set, administration, intravascular1 recall204 reports
- Plum 1425528ICU Medical, Inc. · Set, administration, intravascular1 recall164 reports
- Plum 1427329ICU Medical, Inc. · Set, administration, intravascular214 reports
- Plum 1233912ICU Medical, Inc. · Set, administration, intravascular1 recall131 reports
- ICU Medical 15247-28Icu Medical, Inc. · Set, administration, intravascular1 recall13 reports
- ICU Medical 15339-28Icu Medical, Inc. · Set, administration, intravascular1 recall9 reports
- Lifeshield 1495188ICU Medical, Inc. · Set, administration, intravascular1 recall3 reports
- ICU Medical 15256-28Icu Medical, Inc. · Set, administration, intravascular1 recall1 report
- Plum 1425128ICU Medical, Inc. · Set, administration, intravascular1 recall1 report
- ICU Medical 15951-28Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1495388Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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