Cardinal Health insulated gel pack recalled for infant contraindication
Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.
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 with no reported injuries or illnesses. However, it involves a clear contraindication for a vulnerable population (infants/neonates), making it a risk-of-harm product where injury has not yet been reported, meeting the criteria for severity score 3.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 414,194 units of the Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 distributed nationwide and in Canada. The product should not be used on infants or neonates.
The manufacturer is updating the product labeling to include a clear caution statement: "Not for use on Infants/Neonates." This labeling change will ensure that users, including healthcare workers and caregivers, understand the contraindication and avoid applying the product to this vulnerable population.
Consumers who have this product should not use it on infants or neonates. Watch for updated labeling from Cardinal Health, and if your product does not yet carry the warning statement, take precautions to ensure the product is not applied to infants or neonates.
The recalled product
- Product
- Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Thermal Pack
- Hazard
- Affected units
- 414,194
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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