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