DeRoyal ST Neonatal Dressing Change Kit recall
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the…
Why was DeRoyal ST Neonatal Dressing Change Kit recalled?
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 400 kits
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)