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