DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods
DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation indicates potential for serious adverse health consequences. The uncertain validation of manufacturing test methods on a medical device used for surgical skin preparation creates a risk of harm if the antiseptic effectiveness cannot be confirmed. No injuries have been reported.
Plain-English summary
DeRoyal Industries Inc is recalling 780 kits of the DeRoyal Ultra/Mammo Tray with Prevantics antiseptic swab (SKU/Part Number 89-4990.06) due to uncertain validation of the test methods used during manufacturing. The Prevantics swab contains chlorhexidine gluconate and isopropyl alcohol and is intended for preparation of patient skin prior to surgery or injection.
The affected kits were distributed in the United States to healthcare facilities in Florida, New Jersey, and Tennessee. The recalled lot numbers include 53334442 (exp 05/01/2021), 53815781 (exp 06/01/2022), 54685720 (exp 06/01/2022), 55247529 (exp 03/01/2023), and 55967067 (exp 04/01/2023).
Healthcare facilities and individuals using this product should stop use and contact DeRoyal Industries Inc for instructions regarding return or disposal. No injuries or illnesses have been reported to date.
The recalled product
- Product
- DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- manufacturing-validation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- SKU/Part Number 89-4990.06
- Lot 53815781 (exp 06/01/2022)
- Lot 54685720 (exp 06/01/2022)
- Lot 55247529 (exp 03/01/2023)
- Lot 55967067 (exp 04/01/2023)
Distribution
Distribution scope not specified by the agency.
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