Recall Z-3040-2011 ยท LGZ Warmer, Thermal, Infusion Fluid
Vital Signs Devices, a GE Healthcare Company
enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
| Date | Aug 19, 2011 (initiated Jun 30, 2011) |
| Status | Terminated |
| Reason | enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer. |
| Root cause | Device Design |
| Action | GE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy. |
| Quantity | 1307 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Vietnam |
| 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 |