DeRoyal Industries Inc Recall 89737
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.
DeRoyal Industries Inc Recall 89737 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0879-2022 |
| Event ID | 89737 |
| Event 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. |
| Product Type | Devices |
| Distribution | US distribution to Florida, New Jersey, and Tennessee |
| Quantity | 780 kits |
| Recall Reason | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. |
| Device Classification | 20220413 |
| Device 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) |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220303 |
| Recalling Firm | DeRoyal Industries Inc |
| Initial Notification | Letter |
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