DeRoyal recalls Ultra/Mammo Tray swabs due to uncertain test validation during manufacturing. Affected swabs have specific lot numbers and expiration dates. Consumers should check their product details.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
DeRoyal is recalling swabs for surgical skin prep due to uncertain test validation during manufacturing. This means the swabs' effectiveness and safety aren't fully confirmed, which could affect medical procedures.
The swabs contain chlorhexidine gluconate and isopropyl alcohol. The recall states that test methods used to validate the swabs' quality were uncertain, meaning their effectiveness and safety aren't fully confirmed. This could lead to inadequate skin preparation during medical procedures.
Healthcare professionals using the DeRoyal Ultra/Mammo Tray for patient skin preparation before surgery or injections are most at risk. Patients using these swabs for medical procedures may also be affected.
Check for the DeRoyal Ultra/Mammo Tray with the specific lot numbers listed: 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).
Identify the lot number and expiration date on your DeRoyal Ultra/Mammo Tray swabs to confirm if they are affected.
The recall is due to uncertain validation of test methods used to manufacture the swabs, which means their effectiveness and safety aren't fully confirmed.
The official recall record does not specify a remedy, so you should check with DeRoyal Industries Inc for further instructions.
Yes, the affected lot numbers are 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).
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0879-2022 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0879-2022 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
