DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for pre
Summary
The FDA issued a Class II for DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine glucon by DeRoyal Industries Inc. Reason: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products..
Details
Source
Device Recall
External ID
Z-0879-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Lot/Code Info: SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023)
Quantity Affected: 780 kits
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-03
Company
Powell, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeRoyal Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeRoyal Industries Inc have FDA actions?
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0879-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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