Smiths Medical ASD, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1145-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: October 31, 2016

Date Posted: February 15, 2017

Recall Number: Z-1145-2017

Event ID: 75557

Reason for Recall:

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

Status: Terminated

Product Quantity: 33

Code Information:

S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.

Distribution Pattern:

Internationally to Finland

Voluntary or Mandated:

Voluntary: Firm initiated