The Recall Desk
SevereFDA (Devices)·Z-1566-2023·Announced 2023-05-24

Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

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: This recall is classified as FDA Class I, which requires immediate notification and indicates the defect could directly impact device performance and patient safety. No illnesses or injuries have been reported in the source text, but the FDA's Class I designation reflects the serious potential for harm from premature battery failure in an infusion system.

Plain-English summary

ICU Medical Inc is recalling replacement batteries (CSB BATTERY, List Number SUB0000594) used in Plum A+ and Plum A+3 infusion pump systems. The recall affects 23,815 units distributed worldwide.

Due to a manufacturing defect from the battery supplier, affected batteries may experience loss of capacity earlier in the battery lifecycle than expected. This results in decreased overall battery runtime earlier than anticipated.

The recall applies to all replacement batteries with serial codes where the first two characters are "22" or lower.

The recalled product

Product
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Manufacturer
ICU Medical Inc
Category
Medical Device
Hazard
  • battery-failure
  • device-malfunction

Distribution

Distribution scope not specified by the agency.

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