FDAFDA · Food and drugs·Recall number Z-1444-2014
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
Published April 16, 2014 · Recall initiated: March 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- 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.
- Lot
- 2513261 2531612 2540540 2545044 2588656
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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