FDA-Device2021-10-06Class I
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Deroyal Industries, Inc. Lafollette
Hazard
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
Sold states
US distribution in Florida and South Carolina.
Affected count
2880 units
Manufactured in
1501 E Central Ave, N/A, La Follette, TN, United States
Products
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2021Don't want to check this manually?
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