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.
Reported: April 13, 2022 Initiated: March 3, 2022 #Z-0878-2022
Product 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.
Reason for Recall
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 400 kits
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DeRoyal Industries Inc. Units affected: 400 kits.
Why was this product recalled? ▼
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0878-2022.
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