Recall Z-1972-2012 ยท LGZ Warmer, Thermal, Infusion Fluid
Vital Signs Devices, a GE Healthcare Company
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
| Date | Jul 9, 2012 (initiated Feb 20, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included customer instructions and a Customer Response Form to be completed and returned to the firm. Contact Customer Service at 1-800-932-0760 for questions regarding this recall. |
| Quantity | 11803 cases |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060537 | EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 Enginivity, LLC, Jun 8, 2006 |