CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date
CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.
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: The recall is classified as FDA Class II, and the hazard involves a medical device for infants that may not meet specifications, representing a risk of harm where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling the TransWarmer Infant Transport Mattress with WarmGel (P/N 20421) and the private label NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel (P/N V6390). These devices are used to provide warmth during the transport of infants within hospitals or between hospitals.
The recall was initiated because the products are not labeled with an expiration date. The source text indicates that units without this labeling may not meet specification. The agency classifies this as a Class II recall.
The recall affects 4,807,566 units distributed worldwide, including the United States and various international markets. Consumers and healthcare facilities should stop using these products and contact the manufacturer for instructions.
The recalled product
- Product
- CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 4,807,566
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)
- Product with no lot/ expiration date on the product label
Distribution
Distributed nationwide across the United States.
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