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Recall Observatory FDA recall evidence

Device product

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.

Z-0878-2022

March 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 89737
Status
Terminated
Classification
Class II
Quantity
400 kits
Official record key
device-enforcement:Z-0878-2022

Official wording

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

Code information: SKU/Part Number 47-670.06; UDI 00749756562942 Lot Numbers (Expiration Date): Lot 52585717 (exp 07/01/2021), Lot 52818525 (exp 07/01/2021), Lot 54354867 (exp 04/01/2022), Lot 55502331 (exp 04/01/2022)

Distribution pattern: US distribution to Florida, New Jersey, and Tennessee

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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