FDAFDA · Food and drugs·Recall number Z-1972-2012
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 administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Published July 18, 2012 · Recall initiated: February 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vital Signs Devices, a GE Healthcare Company
- Distributor
- Nationwide Distribution.
- Lot
- a) 510(k): K060537 b) Medical device listing number: D071942 All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products: Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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