DeRoyal Ultra/Mammo Tray recall
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin…
Why was DeRoyal Ultra/Mammo Tray recalled?
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023)
- Product
- DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 780 kits
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)