Z-0879-2022 Class II Terminated
FDA device recall Z-0879-2022 was initiated by DeRoyal Industries Inc on Mar 3, 2022 and is designated Class II. Reason for recall: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. The recall status is terminated (terminated Sep 15, 2022). Affected quantity: 780 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Mar 3, 2022
- Termination Date
- Sep 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 780 kits
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.
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 Pattern
US distribution to Florida, New Jersey, and Tennessee
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0879-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026