Recall Z-2376-2021— Smiths Medical ASD Inc.

Name: FDA recall Z-2376-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-08-06. It names one FDA 510(k) clearance: K072080. Product: NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129. Reason: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Ongoing
Initiated: 2021-08-06
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K072080 — NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,Smiths Medical Asd, Inc.·cleared 2008-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

Reason for recall

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.