FDA Device recall Z-0878-2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for prepara…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for prepara… by Deroyal Industries, citing A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0878-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-03 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | FL, NJ, TN |
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.
Reason
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Identifiers
| code_info | SKU/Part Number 47-670.06; UDI 00749756562942 Lot Numbers (Expiration Date): Lot 52585717 (exp 07/01/2021), Lot 5281…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2022%22
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