ICU Medical recalls ASM Replacement Battery (Component SUB0000594) with lot numbers 5660479 due to potential early capacity loss. Affected units may have reduced runtime.
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
ICU Medical is recalling a specific replacement battery (Component SUB0000594) because it may lose capacity earlier than expected, leading to shorter battery life. This could affect medical devices that rely on this battery.
The battery may lose capacity earlier than expected due to a manufacturing defect from the battery supplier. This can cause the battery to run out of power sooner than normal, potentially affecting medical devices that depend on it.
Medical device users who own the recalled battery (Component SUB0000594) with lot number 5660479 are affected. Patients using medical devices with this battery may be at risk if the battery fails prematurely.
Check for the Component Number SUB0000594 on the battery. The affected lot number is 5660479. This battery is sold by ICU Medical.
Identify the Component Number and lot number on the battery to confirm if it is affected.
The battery may experience early capacity loss due to a manufacturing defect from the battery supplier, leading to shorter runtime than expected.
Check the Component Number and lot number on the battery. If it matches SUB0000594 and lot 5660479, contact ICU Medical for further instructions.
The recall states potential early capacity loss, but no specific injury risk is mentioned. The danger level is low risk.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1568-2023 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1568-2023 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
