Reported May 24, 2023 · Ongoing

ASM Replacement Battery, Component Number SUB0000594

ICU Medical Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • ASM Replacement Battery, Component Number SUB0000594
Lot codes and dates
  • Lot Numbers5660479
Amount recalled
344 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.