FDA recall Z-0880-2022

DeRoyal Industries Inc · Class II · 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.

Reason for recall

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

Distribution

US distribution to Florida, New Jersey, and Tennessee

Key facts

Status
Terminated
Initiation date
2022-03-03
Report date
2022-04-13
Termination date
2022-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0880-2022