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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- DeRoyal Industries Inc
- Reason for Recall:
- A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0878-2022
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