Reported Oct 6, 2021 · Terminated

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Deroyal Industries, Inc. Lafollette

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Deroyal Industries, Inc. Lafollette · 1501 E Central Ave · La Follette, TN · 37766-2892

Is this the product you have?

  • DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Lot codes and dates

34 of 34 products

Products covered by this recall
#Product as published
1Lot 46459298 exp 10/01/2021
2Lot 47042849 exp 11/01/2021
3Lot 47217717 exp 01/01/2022
4Lot 47461066 exp 04/10/2022
5Lot 47525103 exp 04/01/2022
6Lot 47696113 exp 05/01/2022
7Lot 48210787 exp 07/01/2022
8Lot 49049665 exp 10/01/2022
9Lot 47525103 exp 04/01/2022
10Lot 49101769 exp 07/01/2022
11Lot 49215918 exp 11/01/2022
12Lot 49291064 exp 11/1/2022
13Lot 49351178 exp 01/01/2023
14Lot 49455989 exp 01/01/2023
15Lot 49683631 exp 01/01/2023
16Lot 50920251 exp 03/01/2023
17Lot 51081699 exp 08/01/2023
18Lot 51253374 exp 08/01/2023
19Lot 52004222 exp 10/01/2023
20Lot 52658453 exp 02/01/2024
Amount recalled
2880 units

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 18, 2023 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.