Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

Date: 09/15/2021

Product  type: Medical Device

Recalled Product
Product Names: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set
Product Codes: See recall database
Model Numbers: See full list of affected medical devices
Manufacturing Dates: January 1994 to July 2021
Distribution Dates: January 1994 to present
Devices Recalled in the U.S.: 520,163
Date Initiated by Firm: August 6, 2021

US-FDA LInk: https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-normoflo-irrigation-fluid-warmers-and-warming-sets-due-possibility-harmful