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Terminated

DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

FDA Recall Z-0878-2022 · Posted None

Recall StatusTerminated
Product CodeOXQ
Date Initiated2022-03-03
Date Terminated2022-09-15
Product Quantity400 kits

Reason for Recall

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Firm Action

DeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal.

Root Cause

Process control

Distribution Pattern

US distribution to Florida, New Jersey, and Tennessee

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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