The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2094-2021·Announced 2021-07-28

Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

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 documented risk of chemical burns, thermal burns, and eye injury from splashing contents during activation. However, no illnesses or injuries are reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).

Plain-English summary

Cardinal Health 200, LLC is recalling the Infant Heel Warmer with Attachment Tab (SKU MH00002T), nonsterile. These medical devices are activated by squeezing the pouch, which mixes internal substrates to create an exothermic chemical reaction that warms the pouch. The warmer is then applied to an infant's heel to assist with blood draws. A total of 926,425 units have been distributed nationwide across all U.S. states and the District of Columbia. All lot numbers are included in this recall.

The recall was initiated due to reports of pack rupture or leaking that can occur during the activation process. When the pouch ruptures or leaks, the heated liquid inside may splash into the user's eyes or onto the infant's skin. Contact with this liquid may cause rash, burn, or inflammation.

Consumers and healthcare providers should discontinue use of the recalled heel warmers and remove them from inventory. If the device must be used, activate it away from the user's face and away from the infant to reduce the risk of splashing. Anyone who has been injured or wishes to report an adverse event should contact Cardinal Health.

The recalled product

Product
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T 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
Hazard
Affected units
926,425

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.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

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