ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss
ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.
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 medical device recall. Although the agency classification ensures a minimum severity of Severe (4), the absence of reported illnesses or injuries prevents a Critical (5) score.
Plain-English summary
ICU Medical Inc is recalling the ASM Replacement Battery, Component Number SUB0000864. The recall is due to a manufacturing defect from the battery supplier. This defect may cause affected batteries to experience loss of capacity earlier in the battery lifecycle than expected.
Due to the manufacturing defect, overall battery runtime may decrease earlier in the battery lifecycle than expected. This could affect the performance of devices utilizing these batteries.
The recall affects 9984 units distributed worldwide. The affected lot numbers are: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, and 8408757.
The recalled product
- Product
- ASM Replacement Battery, Component Number SUB0000864
- Manufacturer
- ICU Medical Inc
- Affected units
- 9,984
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 (7)
- Lot Numbers: 6036488
- 6827738
- 6827739
- 6827740
- 8408750
- 8408755
- 8408757
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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