Recall Z-2008-2009 ยท LGZ Warmer, Thermal, Infusion Fluid
Enginivity LLC
Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.
| Date | Sep 4, 2009 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | 1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring). |
| Root cause | Device Design |
| Action | Vital Signs, Inc. issued Product Safety Notification on March 23, 2009 informing users of potential EMI and fluid ingress issues. All warmers in the field will be replaced beginning in May 2009. |
| Quantity | 3052 units |
| Distribution | Worldwide Distribution -- USA, Philippines, Saudi Arabia, India, Israel, Australia, Mexico, Germany, Republic of Singapore, China, Guatemala, Switzerland, Dubai United Arab Emirates, New Zealand, Malaysia, India, Ecuador, & United Kingdom. |
| 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 |