Infant Heel Warmers w/strap recall: Labeling Error
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Why was Infant Heel Warmers w/strap recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units are impacted
- Product
- Infant Heel Warmers w/strap, Reference # 989805603201 1223
- Recalling firm
- Philips North America Llc
- Quantity
- 5,164,600 units
- Distribution
- US Nationwide and Canada.
- Recall date
- January 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)