Device product
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Z-1444-2014
Product summary
- Event
- Event 67714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 870 units
- Official record key
device-enforcement:Z-1444-2014
Official wording
Reason: Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Code information: 2513261 2531612 2540540 2545044 2588656
Distribution pattern: Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Derived failure modes
-
Unknown
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged