The Recall Desk
SevereFDA (Devices)·Z-1568-2023·Announced 2023-05-24

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.

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: 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
Category
Medical Device — Battery Component
Hazard
  • capacity-loss
  • runtime-decrease

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.

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