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.
Check against the official notice below — it lists the full affected range.
DeRoyal Industries Inc. recalled the DeRoyal ST Neonatal Dressing Change Kit because of a problem with one of its components—the PDI Prevantics antiseptic swab (which contains chlorhexidine gluconate and isopropyl alcohol). The swab was recalled due to uncertain validation of the test methods used during manufacturing. Approximately 400 kits were distributed in the United States to Florida, New Jersey, and Tennessee.
The affected kits have SKU/Part Number 47-670.06 and UDI 00749756562942, with the following lot numbers and expiration dates: Lot 52585717 (expires 07/01/2021), Lot 52818525 (expires 07/01/2021), Lot 54354867 (expires 04/01/2022), and Lot 55502331 (expires 04/01/2022). The source does not specify a remedy or what an affected consumer should do.
Written by software from the official notice below. Not reviewed by a lawyer.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
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: US distribution to Florida, New Jersey, and Tennessee Quantity: 400 kits Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.