DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

Date: 10/06/2021

Product type:  Null

  • Product Names: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set 
  • Product Codes for CYSTO Pack PGYBK/89-5721.03 and GU TUR BASIN SET PGYBK/89-6425.07: See Recall Database Entry
  • Manufacturing Dates: November 8, 2017 to July 22, 2021
  • Distribution Dates: November 29, 2017 to July 21, 2021
  • Devices Recalled in the United States: 2,856
  • Date Initiated by Firm: September 2, 2021

US-FDA Link: