Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk
Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords may overheat, posing a fire or thermal injury risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of fire and thermal injury, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Ohmeda Medical is recalling specific Giraffe Bedded Warmer and Panda Warmer infant radiant warmers. These devices provide infrared heat to neonates who cannot regulate their own body temperature. The recall involves 5,993 units distributed worldwide, including the United States, Puerto Rico, and various international locations.
The recall is due to a defect in certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords. These cords may overheat where they connect to the wall outlet. Overheating can result in fire, charring, smoke, or sparking, which could cause thermal injury to patients or staff.
Healthcare facilities and consumers should stop using the affected units immediately. The specific serial numbers and lot codes for the affected power cords are detailed in the attached spreadsheet referenced in the recall documentation. Users should contact Ohmeda Medical for instructions on replacement or repair.
The recalled product
- Product
- Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's…
- Manufacturer
- Ohmeda Medical
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)
- See Attached Spreadsheat
Distribution
Part of a larger recall action
This product is one of 11 recalled by Ohmeda Medical 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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