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 1 Lot 46459298 exp 10/01/2021 2 Lot 47042849 exp 11/01/2021 3 Lot 47217717 exp 01/01/2022 4 Lot 47461066 exp 04/10/2022 5 Lot 47525103 exp 04/01/2022 6 Lot 47696113 exp 05/01/2022 7 Lot 48210787 exp 07/01/2022 8 Lot 49049665 exp 10/01/2022 9 Lot 47525103 exp 04/01/2022 10 Lot 49101769 exp 07/01/2022 11 Lot 49215918 exp 11/01/2022 12 Lot 49291064 exp 11/1/2022 13 Lot 49351178 exp 01/01/2023 14 Lot 49455989 exp 01/01/2023 15 Lot 49683631 exp 01/01/2023 16 Lot 50920251 exp 03/01/2023 17 Lot 51081699 exp 08/01/2023 18 Lot 51253374 exp 08/01/2023 19 Lot 52004222 exp 10/01/2023 20 Lot 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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