The Recall Desk
HighFDA (Devices)·Z-0878-2022·Announced 2022-04-13

DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with uncertain manufacturing test method validation. No illnesses or injuries reported in source. The hazard is theoretical rather than confirmed, placing it at level 3.

Plain-English summary

DeRoyal Industries Inc is recalling 400 units of the DeRoyal ST Neonatal Dressing Change Kit, which contains a Prevantics antiseptic swab designed for patient skin preparation prior to surgery or injection. This medical device kit is used in healthcare settings for neonatal patients.

The recall is due to uncertain validation of the test methods used during manufacturing. The company cannot verify that the manufacturing processes met intended specifications.

The affected kits were distributed in the United States to healthcare facilities in Florida, New Jersey, and Tennessee. The recalled kits are identified by SKU/Part Number 47-670.06 and UDI 00749756562942. Affected lot numbers and expiration dates are: Lot 52585717 (07/01/2021), Lot 52818525 (07/01/2021), Lot 54354867 (04/01/2022), and Lot 55502331 (04/01/2022). Healthcare providers who have received these kits should stop use and contact DeRoyal Industries Inc for return instructions.

The recalled product

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.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Preparation Kit
Hazard
  • test-validation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • SKU/Part Number 47-670.06
  • Lot 52818525 (exp 07/01/2021)
  • Lot 54354867 (exp 04/01/2022)
  • Lot 55502331 (exp 04/01/2022)

Distribution

Distribution scope not specified by the agency.

Related recalls

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