The Recall Desk
SevereFDA (Devices)·Z-1565-2023·Announced 2023-05-24

Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall for a critical medical device component. The rule states never go below 4 for FDA Class I classifications. No deaths or reported illnesses are stated in the source text, preventing a higher classification.

Plain-English summary

ICU Medical Inc is recalling 28,656 replacement batteries (List Number SUB0000864) found in the Plum 360 Infusion System (List Number 30010). The recall is due to a manufacturing defect from the battery supplier.

Affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected, resulting in decreased overall battery runtime. The defect affects all devices containing CSB BATTERY with the first two characters displaying as 22 or lower.

The Plum 360 Infusion System is a critical medical device used to deliver medications and fluids to patients. Premature battery failure could interrupt treatment. Healthcare providers and patients using affected units should contact ICU Medical Inc immediately for replacement instructions and guidance.

The recalled product

Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion System / Battery
Hazard
  • battery-failure
  • device-malfunction
  • capacity-loss

Distribution

Distribution scope not specified by the agency.

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