Smiths Medical ASD, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1105-2017)

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:

NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.

Product Classification:

Class II

Date Initiated: October 25, 2016

Date Posted: February 1, 2017

Recall Number: Z-1105-2017

Event ID: 76190

Reason for Recall:

Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.

Status: Terminated

Product Quantity: 1

Code Information:

S105B0061

Distribution Pattern:

Distribution in the foreign country of Sweden

Voluntary or Mandated:

Voluntary: Firm initiated