La Follette, TN, United States
Deroyal Industries, Inc. Lafollette recalls
3 recalls recorded since 2018, most recently on 2 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 2 September 2021
- Terminated
- 18 December 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2499-2021
- DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Terminated Class II Medical devices
- Recall started
- 6 February 2020
- Terminated
- 11 February 2021
- Reason
- The sterile packaging has the potential to be compromised.
- Distribution
- International distribution of Kuwait City, Kuwait.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1483-2020
- Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
Terminated Class II Medical devices
- Recall started
- 4 February 2020
- Terminated
- 1 April 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1416-2020, Z-1419-2020, Z-1412-2020, Z-1410-2020, Z-1414-2020, Z-1413-2020, Z-1417-2020, Z-1418-2020, Z-1411-2020, Z-1415-2020
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
- and 2 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.