The Recall Desk
SevereFDA (Devices)·Z-2448-2024·Announced 2024-08-21

Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were 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: This is an FDA Class I device recall. Battery capacity loss in infusion pumps could interrupt essential medication delivery, though no illnesses or injuries are reported. FDA Class I classification requires a minimum Severe rating per the rubric.

Plain-English summary

ICU Medical Inc is recalling replacement batteries for Plum A+ and Plum A+3 infusion systems. The affected batteries are List Numbers SUB0000594 and SUB0000864. Approximately 14,744 units were distributed worldwide, including to the United States and 17 other countries.

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected. As a result, overall battery runtime may decrease earlier than expected.

This recall affects all users of Plum A+ and A+3 infusion systems with the affected battery list numbers. Consumers and healthcare facilities should verify their equipment serial numbers against the FDA recall information to determine if they have affected devices.

The recalled product

Product
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion pump batteries
Hazard
Affected units
14,744

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234
  • 18077407
  • 18077421
  • 18077507
  • 18077551
  • 18077561
  • 18077621
  • 18077674
  • 18077677
  • 18077701
  • 18077737
  • 18077794
  • 18077797
  • 18077824
  • 18077831
  • 18077897
  • 18077941
  • 18077977
  • 18078084
  • 18078101

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by ICU Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · ICU Medical Inc

See all →

Same hazard · battery capacity loss

See all →