Food, drugs, devices › Deroyal Industries, Inc. Lafollette
Device recall: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA enforcement event 88660 is a device recall by Deroyal Industries, Inc. Lafollette of La Follette, TN, initiated 2 Sep 2021 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 18 Dec 2023. Initiation: voluntary: firm initiated. Deroyal Industries, Inc. Lafollette has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Deroyal Industries, Inc. Lafollette, La Follette, TN.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2499-2021 | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set | 2880 units | Class I | Terminated | 6 Oct 2021 |
Context
Other enforcement events for Deroyal Industries, Inc. Lafollette
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Feb 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Produ | Device | Class II | 1 |
| 4 Feb 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12; | Device | Class II | 10 |
All 3 events for Deroyal Industries, Inc. Lafollette
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution in Florida and South Carolina."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Dec 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.