Reported Jul 26, 2023 · Ongoing

NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

Cardinal Health 200, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337

Is this the product you have?

  • NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Lot codes and dates
    • UDI/DI (Case) 50885380057586
    • (Box) 20885380057585
    • (EA) 10885380057588
    • Lot Number V2S056
Amount recalled
44,500 units

Where it was sold

  • Nationwide

Why it was recalled

Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

This product could cause temporary or reversible health problems — stop using it.

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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, 4:49 PM UTC

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