Reported Apr 13, 2022 · Terminated
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol)…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot Numbers (Expiration Date) 2 Lot 53059743 (exp 06/01/2022) 3 Lot 53632941 (exp 06/01/2022) 4 Lot 53666113 (exp 06/01/2022) 5 Lot 54205909 (exp 06/01/2022) 6 Lot 54279422 (exp 06/01/2022) 7 Lot 54327332 (exp 06/01/2022) 8 Lot 54473313 (exp 06/01/2022) 9 Lot 55573404 (exp 06/01/2022) - Amount recalled
- 1360 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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