The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1508-2017·Announced 2017-03-29

Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk

Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords could overheat, posing a risk of fire or thermal injury.

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 rubric criteria for Severe (score 4) involving significant injury reports or structural defects.

Plain-English summary

Ohmeda Medical is recalling specific Giraffe Bedded Warmer and Panda Warmer models due to a defect in the power cords. The affected power cords, manufactured by Electric-Cord and referred to as 'Taller Bridge' power cords, have the potential to overheat. This overheating can occur where the power cord connects to the wall outlet.

The recall involves 5,993 units distributed worldwide, including 5,080 in the United States (nationwide and Puerto Rico) and 913 outside the US. The distribution list includes the Bahamas, UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela.

The overheating of the power cord could result in fire, charring, smoke, or sparking, which could cause thermal injury. The source text does not specify the exact actions consumers or healthcare facilities should take, such as stopping use or contacting the manufacturer, beyond the fact that the recall is active.

The recalled product

Product
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
Manufacturer
Ohmeda Medical
Category
Medical Device — Infant Radiant Warmers
Hazard

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 11 products in this recall →

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