The Recall Desk
SevereFDA (Devices)·Z-2449-2024·Announced 2024-08-21

Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss

ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.

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 recalls mandate a minimum severity of 4. This recall reports no illnesses or injuries and describes potential (not actual) battery capacity loss. This prevents a Score 5 (Critical) designation, resulting in Score 4 (Severe).

Plain-English summary

ICU Medical Inc. is recalling 130,826 units of Plum 360/A+ spare batteries (Item Number: SUB0000864) due to a manufacturing defect. Affected batteries may experience loss of capacity earlier in their lifecycle than expected, which could result in decreased overall runtime sooner than intended.

The affected batteries were distributed worldwide to the United States and 17 other countries: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay. The recall affects 50 specific lot numbers.

This is an FDA Class I recall. Consumers in possession of affected batteries should contact ICU Medical for replacement information. No illnesses or injuries related to this defect have been reported to date.

The recalled product

Product
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Manufacturer
ICU Medical Inc
Category
Medical Device — Battery / Power Supply
Hazard
Affected units
130,826

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)

  • Item Number: SUB0000864
  • Lot Numbers: 13620902
  • 13588166
  • 13651642
  • 13651688
  • 13651686
  • 13651685
  • 13492940
  • 13498252
  • 13498259
  • 13716418
  • 13716411
  • 13651680
  • 13620909
  • 13716514
  • 13588168
  • 13594285
  • 13620897
  • 13638726
  • 13620893

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

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Same hazard · capacity loss

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