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.
This recall has been terminated (originally issued August 19, 2011).
- Recall Initiated
- June 30, 2011
- Posted
- August 19, 2011
- Terminated
- June 14, 2013
- Recall Number
- Z-3040-2011
- Quantity
- 1307 units
- Firm Location
- Totowa, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
Distribution
Worldwide Distribution - USA (nationwide) and the country of Vietnam
Lot / Code Info
K060537 D071942 Serial numbers: 00110412 00110497 00111507 00111633 00111718 00111719 00111816 00111835 00110790 00110946 00111686 00111691 00111916 00111764 00111787 00111897 00111939 00112078 00112200 00111880 00111906 00111733 00111664 00111668 00111672 00111673 00111699 00111745 00111749 00111771 00111773 00111786 00111807 00111817 00111832 00111865 00111886 00111891 00111898 00111954 00111975 00111996 00111997 00112042 00112071 00112106 00111703
Root Cause
Device Design
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.