ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss
ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.
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: This is an FDA Class I medical device recall, which requires a severity score of at least 4 per regulatory standards. Although no illnesses or injuries have been reported, the FDA Class I classification reflects the potential seriousness of a manufacturing defect affecting battery capacity and runtime.
Plain-English summary
ICU Medical Inc is recalling the ASM Replacement Battery, Component Number SUB0000594. The recall stems from a manufacturing defect in batteries supplied by the battery supplier.
Affected batteries may experience loss of capacity earlier than expected in the battery lifecycle. Additionally, overall battery runtime may decrease earlier than designed in these batteries.
A total of 344 units have been distributed worldwide and are identified by Lot Number 5660479.
The recalled product
- Product
- ASM Replacement Battery, Component Number SUB0000594
- Manufacturer
- ICU Medical Inc
- Affected units
- 344
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 (1)
- Lot Numbers: 5660479
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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.
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