FDAFDA · Food and drugs·Recall number Z-1443-2014
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. 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
- 2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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