The Recall Desk
HighFDA (Devices)·Z-2095-2021·Announced 2021-07-28

Infant Heel Warmer Recalled Due to Risk of Rupture and Contents Splashing

Cardinal Health is recalling 2.9 million infant heel warmers that may rupture or leak during activation, potentially splashing heated contents onto infants' eyes or skin and causing rash, burn, or inflammation.

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 Class II FDA recall for a heating device with documented reports of rupture or leaking during activation that could cause contact injuries including rash, burn, and inflammation. No injuries have been reported, making this a risk-of-harm product without documented harm.

Plain-English summary

Cardinal Health 200, LLC is recalling approximately 2,911,064 units of Infant Heel Warmer (SKU MH00002N), a nonsterile product designed to warm an infant's heel to facilitate blood draws. The warmer is activated by squeezing the pouch, which triggers an exothermic chemical reaction that heats the contents.

The manufacturer has received reports that the pouch may rupture or leak during the activation process. When this occurs, the heated liquid contents can splash onto the infant or into the eyes of the user. Contact with the liquid inside the pouch can cause rash, burn, and inflammation.

A caution statement is being added to remind users to activate the warmer away from the infant's face and their own face. The recalled product has been distributed nationwide to healthcare facilities in all U.S. states and Washington, D.C. All lot numbers are affected by this Class II recall.

The recalled product

Product
Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Neonatal Warming Device
Hazard
  • rupture
  • burn-injury
  • rash
  • eye-splash

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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