Recall of Infant Heel Warmers Due to Potential Breakage and Spillage
The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (skin/eye irritation) from a medical device defect, which aligns with the 'High' severity criteria for risk-of-harm products where serious injury has not been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 68,800 units of Infant Heel Warmers (Item Code: MH00002N) manufactured by Covidien LLC. The recall is due to a defect where the warmers may break during activation, resulting in the spillage of their contents onto patients or healthcare workers. This spillage poses a risk of potential skin or eye irritation.
The affected products are distributed worldwide, including in the United States, Canada, Mexico, Panama, and Japan. The specific lot codes involved in this recall are 312209X, 313033X, 313304X, 314307X, 315108X, 318417X, 322119X, 322514X, and 322817X. These devices are intended for the application of heat to an infant's heel for blood sampling.
Healthcare facilities and consumers should stop using the affected units immediately. Users should check the lot codes on their products against the list provided in this notice. If the lot code matches, the product should be returned to the supplier or the manufacturer for a refund or replacement, as directed by the recalling firm.
The recalled product
- Product
- Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Infant Care
- Affected units
- 68,800
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien 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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- High
- Severe