The Recall Desk
HighFDA (Devices)·Z-0188-2023·Announced 2022-11-16

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
  • burn-injury

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.

Related recalls

Same category