The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1510-2017·Announced 2017-03-29

Ohmeda-Ohio CarePlus Incubator Recall Due to Power Cord Overheating Risk

Ohmeda Medical is recalling CarePlus Incubators because certain power cords may 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 'Severe' criteria for significant injury reports or structural defects in medical devices.

Plain-English summary

Ohmeda Medical is recalling specific units of the Ohmeda-Ohio CarePlus Incubator. These devices provide a controlled thermal environment for neonates who are unable to regulate their own body temperature. The recall involves 5,993 units distributed worldwide, including 5,080 in the United States and Puerto Rico, and 913 in other countries such as the UK, Canada, and Brazil.

The recall is due to a defect in certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords. These cords have the potential to overheat at the connection point with the wall outlet. This overheating can result in fire, charring, smoke, or sparking, which could cause thermal injury to patients or staff.

Healthcare facilities and consumers should identify affected units by checking the attached spreadsheet for specific code information. If a unit is affected, it should be removed from service immediately to prevent potential fire or injury hazards.

The recalled product

Product
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to…
Manufacturer
Ohmeda Medical
Category
Medical Device — Neonatal Incubator
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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