Device recall

Z-1145-2017: HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline…

FDA device recall · Class III · Smiths Medical ASD, Inc.

Key facts

Recall number (Z-number) Z-1145-2017
Recall event 75557
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.
Product code LGZ
Recalling firm Smiths Medical ASD, Inc.
Recall class Class III
Status Terminated
Termination date Nov 27, 2017
FEI number 2183502

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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