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Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

FDA Recall #Z-0509-2022 — Class II — November 29, 2021

Recall #Z-0509-2022 Date: November 29, 2021 Classification: Class II Status: Ongoing

Product Description

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

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.

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2,925,800 units

Distribution

US Nationwide and Canada.

Code Information

All units are impacted

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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