Z-0878-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- March 3, 2022
- Termination Date
- September 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 kits
Product Description
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.
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 Pattern
US distribution to Florida, New Jersey, and Tennessee
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)