The Recall Desk
SevereFDA (Devices)·Z-1567-2023·Announced 2023-05-24

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.

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: 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
Category
Medical Device — Battery / Power Supply
Hazard
  • manufacturing-defect
  • battery-capacity-loss

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.

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