enFlow IV Fluid Warmer — Class II medical device recall Z-1972-2012
Terminated recall by Vital Signs Devices, a GE Healthcare Company, reported 2012-07-18, distributed nationwide. The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for produc
| Recall number | Z-1972-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Signs Devices, a GE Healthcare Company, Totowa, NJ, United States |
| Recall initiated | 2012-02-20 |
| Classified | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 11,803 cases |
| Model numbers | 100, 120, 200 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.