The Recall Desk
HighFDA (Devices)·Z-0186-2023·Announced 2022-11-16

Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

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 an FDA Class II medical device recall for a product contraindicated in a vulnerable population (infants/neonates). Although no illnesses or injuries have been reported, the product represents a risk-of-harm to this sensitive population group, meeting the criteria for High severity.

Plain-English summary

Cardinal Health 200, LLC is recalling the Cardinal Health GEL PACK REUSABLE, SMALL (Catalog Number 70204). The recall affects 409,738 units distributed nationwide and in Canada.

The product should not be used on infants or neonates. Cardinal Health is updating product labeling to include a caution statement reading "Not for use on Infants/Neonates."

Healthcare facilities, clinics, and individuals who have received this product should discontinue use on infants and neonates. Users are advised to review and follow the updated labeling instructions.

The recalled product

Product
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Reusable Gel Pack
Hazard
  • contraindication-neonates

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.

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