Z-1972-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- February 20, 2012
- Termination Date
- August 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11803 cases
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.
Distribution Pattern
Nationwide Distribution.
Code Information
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