Fisher Brand Infant Heel Warmers Recalled for Burn Risk
CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.
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 involves a risk-of-harm product (burn injury) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
CooperSurgical, Inc. is recalling Fisher Brand Gel Infant Heel Gel Warmers (Cat. No. 22-024647) and Fisher Brand Liquid Infant Heel Warmer (Cat. No. 22-024646). These medical devices are used to provide gentle heat to increase blood flow and enhance infant blood sample collection. The recall involves 8,865,584 units that were distributed nationwide in the United States and internationally to Australia, Bahrain, Bermuda, Canada, France, Latvia, Libya, Mexico, New Zealand, Qatar, Saudi Arabia, Singapore, and the United Kingdom.
The recall is being conducted because products without an expiration date have the remote potential for minor burn. The source text does not specify a lot number or expiration date for the affected units, noting only that they lack these identifiers. No illnesses or injuries have been reported in the source text.
Healthcare facilities and consumers should stop using these products immediately. CooperSurgical, Inc. is the recalling firm responsible for managing the recall. Users should contact the manufacturer for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Infant Care
- Hazard
- Affected units
- 8,865,584
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)
- Products without an expiration date and lot number
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by CooperSurgical, Inc. 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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