Cardinal Health Reusable Gel Pack Restricted for Infants
Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.
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: FDA Class II recall for a risk-of-harm product (thermal injury potential) affecting vulnerable infants and neonates without reported injuries. Precautionary labeling update to prevent potential harm.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 567,475 units of its HOT AND COLD GEL PACK REUSABLE, Medium (Cat. 70304), distributed nationwide and in Canada.
The product should not be used on infants and neonates due to thermal injury risk. The company will update product labeling to include a caution statement: "Not for use on Infants/Neonates."
Consumers should not use this product on infants or neonates. Those who have purchased the affected units should ensure they are not used on this population. No injuries have been reported.
The recalled product
- Product
- Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Thermal Therapy
- Hazard
- Affected units
- 567,475
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 lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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