Device product
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
Z-1145-2017
Product summary
- Event
- Event 75557
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33
- Official record key
device-enforcement:Z-1145-2017
Official wording
Reason: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Code information: S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
Distribution pattern: Internationally to Finland
Derived failure modes
-
Unknown
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.