Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: capacity-loss
decreased-runtime
battery-failure-risk
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 →

Same manufacturer · ICU Medical Inc

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Same hazard · capacity loss