Recall Z-1972-2012— Vital Signs Devices, a GE Healthcare Company
Class II · Terminated
Class II FDA medical device recall by Vital Signs Devices, a GE Healthcare Company, initiated 2012-02-20, terminated 2013-08-19. It names one FDA 510(k) clearance: K060537. 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 administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.. Reason: 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..
- Recalling firm
- Vital Signs Devices, a GE Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-02-20
- Terminated
- 2013-08-19
- Firm location
- Totowa, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.