Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions
Ohmeda Medical is recalling Giraffe Omnibed infant incubators because cleaning guidelines failed to prevent debris buildup, creating a potential infection 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 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 risk-of-harm product (infection source) where the hazard is identified but specific injury counts are not reported in the source text, fitting the High severity criteria.
Plain-English summary
Ohmeda Medical is recalling Giraffe Omnibed infant incubators and warmers due to a potential safety issue involving the canopy seals. The device is a combination unit used to provide controlled heat to neonates who cannot regulate their own body temperature. The recall covers units shipped from 2000 to 2011 with serial numbers ranging from HDGD00001 to HDGQ50183.
Healthcare professionals reported that debris built up around the edge of the canopy seal, which can serve as a source of infection. The FDA concluded that the cleaning and care guidelines provided by the manufacturer were inadequate for effective cleaning. Specifically, the instructions did not direct users to remove the canopy seal prior to cleaning, leading to the accumulation of debris.
The affected devices were distributed worldwide, including domestic nationwide and foreign distribution. Healthcare facilities using these devices should review their cleaning protocols to ensure the canopy seal is removed and cleaned appropriately to mitigate the risk of infection.
The recalled product
- Product
- Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same…
- Manufacturer
- Ohmeda Medical
Distribution
Distributed nationwide across the United States.
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