GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues
Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.
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 (potential tissue injury) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Vital Signs Devices, a GE Healthcare Company, is recalling the enFlow Warmer Strap. The recall involves 11,803 cases of the product, which was distributed nationwide. The strap is sold separately and is also included as an accessory in various enFlow IV Fluid Warmer products used in military, domestic, and clinical environments.
The recall is being conducted because the enFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours. The source text notes that all enFlow Warmer Straps in the field present a potential for tissue injury.
Healthcare professionals and consumers who have these straps should stop using them. The product is intended for warming blood, blood products, and intravenous solutions prior to administration to help prevent hypothermia.
The recalled product
- Product
- enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to…
- Manufacturer
- Vital Signs Devices, a GE Healthcare Company
- Affected units
- 11,803
Distribution
Distributed nationwide across the United States.
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