Recall Z-2499-2021— Deroyal Industries, Inc. Lafollette

Name: FDA recall Z-2499-2021
Creator: U.S. Food and Drug Administration
Published: 2021-09-02

Class I · Terminated

Class I FDA medical device recall by Deroyal Industries, Inc. Lafollette, initiated 2021-09-02, terminated 2023-12-18. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set. Reason: 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..

Recalling firm: Deroyal Industries, Inc. Lafollette
Classification: Class I
Status: Terminated
Initiated: 2021-09-02
Terminated: 2023-12-18
Firm location: La Follette, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

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

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.

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