Cardinal Health Insulated Gel Pack recalled; not safe for infants
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
What this means for you
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 risk-of-harm product where no injuries have been reported, meeting the rubric criterion for Score 3 (High). The FDA Class II designation and absence of reported illness prevent a higher score.
Plain-English summary
Cardinal Health 200, LLC is recalling the INSULATED GEL PACK REUSABLE, LARGE (Cat. 80104) distributed nationwide and in Canada. Approximately 1,209,260 units are affected across all lot codes.
The product is not safe for use on infants or neonates. The company will add a warning label that reads: 'Not for use on Infants/Neonates.'
If you have this product, do not use it on infants or neonates. Healthcare facilities and retailers should ensure the warning label is in place.
The recalled product
- Product
- Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device
- Hazard
- Affected units
- 1,209,260
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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- Severe
- High
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