DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Summary
The FDA issued a Class I for DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Se by Deroyal Industries, Inc. Lafollette. Reason: DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminu.
Details
Source
Device Recall
External ID
Z-2499-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Lot/Code Info: 1) CYSTO PACK PGYBK / 89-5721.03 Lot 46459298 exp 10/01/2021 Lot 47042849 exp 11/01/2021 Lot 47217717 exp 01/01/2022 Lot 47461066 exp 04/10/2022 Lot 47525103 exp 04/01/2022 Lot 47696113 exp 05/01/2022 Lot 48210787 exp 07/01/2022 Lot 49049665 exp 10/01/2022 Lot 47525103 exp 04/01/2022 Lot 49101769 exp 07/01/2022 Lot 49215918 exp 11/01/2022 Lot 49291064 exp 11/1/2022 Lot 49351178 exp 01/01/2023 Lot 49455989 exp 01/01/2023 Lot 49683631 exp 01/01/2023 Lot 50920251 exp 03/01/2023 Lot 51081699 exp 08/01/2023 Lot 51253374 exp 08/01/2023 Lot 52004222 exp 10/01/2023 Lot 52658453 exp 02/01/2024 Lot 53216841 exp 02/01/2024 Lot 53666480 exp 09/01/2024 Lot 54367035 exp 01/01/2025 2) GU TUR BASIN SET PGYBK / 89-6425.07 Lot 52173376 exp 10/1/2021 Lot 52902866 exp 12/01/2021 Lot 53216518 exp 12/01/2021 Lot 53331541 exp 12/01/2021 Lot 53411946 exp 03/01/2022 Lot 53598712 exp 02/01/2022 Lot 53784881 exp 09/01/2022 Lot 53888656 exp 03/01/2022 Lot 53964621 exp 03/01/2022 Lot 54009801 exp 08/01/2022 Lot 54246494 exp 09/01/2022
Quantity Affected: 2880 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
La Follette, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Deroyal Industries, Inc. Lafollette) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Deroyal Industries, Inc. Lafollette have FDA actions?
This is the only FDA action we have on record for Deroyal Industries, Inc. Lafollette in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2499-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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