Smiths Medical ASD, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1443-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 17, 2014

Date Posted: April 16, 2014

Recall Number: Z-1443-2014

Event ID: 67714

Reason for Recall:

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

Status: Terminated

Product Quantity: 393,210

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated