Philips Recalls Cardinal Health Tiny Toes Infant Heel Warmers
Philips Electronics North America is recalling Cardinal Health Tiny Toes infant heel warmers because they may cause first and second degree burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of first and second degree burns, which constitutes significant injury potential under the rubric for Severe recalls.
Plain-English summary
Philips Electronics North America Corporation is recalling Cardinal Health Tiny Toes infant heel warmers, model 11470-010T. The recall involves 7,327,100 individual units that were distributed in Moberly, MO.
The recall is being issued because the heel warmers may cause first and second degree burns. The agency has classified this as a Class II recall.
Consumers should stop using the affected heel warmers immediately. The source text does not provide specific instructions for disposal or return, but users should discontinue use to prevent injury.
The recalled product
- Product
- Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Infant Care
- Hazard
- Affected units
- 7,327,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All product in distribution
Distribution
Distribution scope not specified by the agency.
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