Infant Heel Warmer Recalled Due to Burst and Leaking
Cardinal Health is recalling 44,500 NovaPlus Infant Heel Warmers from lot V2S056 due to reports of bursting and leaking. Units were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for an infant heating product with reported failure mode (burst/leaking) that poses risk of harm, but no illnesses or injuries have been reported. It fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 44,500 units of the NovaPlus Infant Heel Warmer, Instant Squeeze Activation (Catalog Number V11460-010), lot number V2S056. This is a Class II medical device recall by the FDA.
The company received an increase in complaints of bursting and leaking from the affected lot between mid-April and May.
The affected units were distributed nationwide in the United States. Consumers with questions about this product should contact Cardinal Health 200, LLC or their healthcare provider.
The recalled product
- Product
- NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 44,500
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 (4)
- UDI/DI (Case) 50885380057586
- (Box) 20885380057585
- (EA) 10885380057588
- Lot Number V2S056
Distribution
Distributed nationwide across the United States.
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