FDA recall Z-2147-2023

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-06-16

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2023