DeRoyal recalls DEXMED ACCESS CENTER TRAY swabs due to uncertain test validation in manufacturing. Affected swabs contain chlorhexidine and isopropyl alcohol for surgical skin prep. No remedy specified in official notice.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
DeRoyal is recalling surgical swabs used for skin preparation before procedures because the test methods used to make them weren't properly validated. This could mean the swabs might not work as intended during medical use.
The swabs were made using test methods that weren't properly validated, which could mean they don't work correctly for skin preparation. This might lead to improper sterilization during medical procedures.
Healthcare professionals using the DeRoyal DEXMED ACCESS CENTER TRAY swabs for surgical skin preparation are most at risk. Patients receiving procedures with these swabs may also be affected.
Check for the DeRoyal DEXMED ACCESS CENTER TRAY swabs with SKU 89-5300.07. Lot numbers include 53059743 through 55573404, all expiring June 1, 2022.
Identify the swab lot number and expiration date from the product label.
The official notice states the test methods used to manufacture the swabs weren't properly validated, which could affect their effectiveness.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected swabs.
The official notice does not describe specific safety risks, only that the test validation was uncertain.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0880-2022 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0880-2022 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.
