enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, M
FDA device recall Z-3040-2011 · posted 2011-08-19 · Terminated
Recall details
- Recalling firm
- Vital Signs Devices, a GE Healthcare Company
- Reason for recall
- enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 1307 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Vietnam
- Date initiated
- 2011-06-30
- Date posted
- 2011-08-19
- Date terminated
- 2013-06-14
- Location
- Totowa, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |