FDA-Device2023-07-26Class II
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health 200, LLC
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
44,500 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2023Don't want to check this manually?
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