Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use
Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a labeling deficiency rather than a manufacturing defect or reported safety incident. No illnesses or injuries have been reported. The hazard is theoretical and being addressed through product labeling, which qualifies as Moderate severity under the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling the Cardinal Health Reusable Gel Pack, Hot/Cold Pack (REF 70304A, 4.5 in. x 10 in.). Approximately 129,412 units were distributed nationwide and in Canada. The product is being recalled because it should not be used on infants or neonates, and existing labeling did not adequately communicate this safety restriction.
A caution statement will be added to the product labeling stating: "Not for use on Infants/Neonates."
Consumers who currently own this product should not use it on infants or neonates. Updates regarding revised labeling will be provided by the manufacturer.
The recalled product
- Product
- Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 129,412
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 (2)
- UDI/DI (01)30888499004898
- 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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