Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk
Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.
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 involves a medical device with a stated risk of harm where specific injuries or illnesses have not yet been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Draeger Medical, Inc. is recalling 1,599 units of the Babytherm 8004 and 8010 infant warmers. These Class II medical devices are used in delivery rooms, operating rooms, and neonatal intensive care units to warm premature babies, neonates, and infants. The affected units are identified by serial numbers ranging from ARLN-xxxx to ASFE-xxxx and catalog numbers FR00105 (Babytherm 8010) and 2M30404 (Babytherm 8004).
The recall is due to a risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected. The source text does not specify the exact nature of the injury or the specific failure mode, only the operational condition that presents the risk.
The affected devices were distributed nationwide in the United States, including Puerto Rico and all 50 states. Healthcare facilities and users of these devices should stop using the affected units and contact Draeger Medical for further instructions on the recall.
The recalled product
- Product
- Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates…
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device — Infant Warmer
- Hazard
- Affected units
- 1,599
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)
- 2M30404 (Babytherm 8004)
Distribution
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