FDA recall Z-0506-2022

Product

Infant Heel Warmers w/strap, Reference # 989805603201 1223

Reason for recall

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

Distribution

US Nationwide and Canada.

Key facts

Status

Ongoing

Initiation date

2021-11-29

Report date

2022-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2022