Cardinal Health Insulated Gel Pack Recalled for Infant Safety
Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.
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 classification; however, the recall is precautionary with no reported injuries or illnesses. The product presents a risk to a vulnerable population (infants/neonates) requiring product labeling restriction, meeting the criterion of a risk-of-harm product where injury has not been reported.
Plain-English summary
Cardinal Health is recalling its INSULATED GEL PACK REUSABLE, SMALL (catalog number 80204A). The recall affects all lots of the product, with an estimated 499,997 units distributed nationwide and in Canada.
The product has been determined to be unsuitable for use on infants and neonates. In response, Cardinal Health is updating the product labeling to include a caution statement: 'Not for use on Infants/Neonates.'
Consumers should not use this product on infants or neonates. Review product labeling for the updated caution statement and follow all safety instructions before use.
The recalled product
- Product
- Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device
- Hazard
- Affected units
- 499,997
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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Same hazard · temperature injury
See all →- SevereDeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure
FDA (Devices) · 2014-02-05
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