Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medica
FDA device recall Z-2008-2009 · posted 2009-09-04 · Terminated
Recall details
- Recalling firm
- Enginivity LLC
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 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, Mala
- Date initiated
- 2009-03-23
- Date posted
- 2009-09-04
- Date terminated
- 2012-05-02
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 (K060537) | Enginivity, LLC | 2006-06-08 |