Food, drugs, devices › Deroyal Industries, Inc. Lafollette
Device recall: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Deroyal Industries, Inc. Lafollette (La Follette, TN) initiated this device recall on 4 Feb 2020; FDA lists 10 product records under event 84889, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 1 Apr 2021. 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
"Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination."
Distribution
"US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1410-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12; | 2,100 units total | Class II | Terminated | 11 Mar 2020 |
| Z-1411-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1412-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1413-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1414-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1415-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1416-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1417-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1418-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06 | 2100 units | Class II | Terminated | 11 Mar 2020 |
| Z-1419-2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13 | 2100 units | Class II | Terminated | 11 Mar 2020 |
Context
Other enforcement events for Deroyal Industries, Inc. Lafollette
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Sep 2021 | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set | Device | Class I | 1 |
| 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 |
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: "Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Apr 2021. "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.