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Recall Observatory FDA recall evidence

Device product

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.

Z-0880-2022

March 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 89737
Status
Terminated
Classification
Class II
Quantity
1360 kits
Official record key
device-enforcement:Z-0880-2022

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 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 53632941 (exp 06/01/2022), Lot 53666113 (exp 06/01/2022), Lot 54205909 (exp 06/01/2022), Lot 54279422 (exp 06/01/2022), Lot 54327332 (exp 06/01/2022), Lot 54473313 (exp 06/01/2022), Lot 55573404 (exp 06/01/2022)

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.