FDAFDA · Food and drugs·Recall number Z-0879-2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Published April 13, 2022 · Recall initiated: March 3, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US distribution to Florida, New Jersey, and Tennessee
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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