FDA recall Z-2499-2021

Deroyal Industries, Inc. Lafollette · Class I · device

Product

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Reason for recall

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.

Distribution

US distribution in Florida and South Carolina.

Key facts

Status: Terminated
Initiation date: 2021-09-02
Report date: 2021-10-06
Termination date: 2023-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Follette, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2021