Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use
Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised 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: This product poses a risk of thermal injury to infants and neonates. While no injuries have been reported, the contraindication for a vulnerable population combined with the product's thermal characteristics meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 649,213 units of the INSULATED GEL PACK REUSABLE, MEDIUM (Cat. 80304A) distributed nationwide and in Canada.
The recalled product should not be used on infants or neonates. The current labeling does not adequately convey this contraindication. The manufacturer is revising the product labeling to include a caution statement: "Not for use on Infants/Neonates."
The recalled product
- Product
- Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 649,213
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.
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