Z-0561-2023 Class II Ongoing
FDA device recall Z-0561-2023 was initiated by DeRoyal Industries Inc on Nov 3, 2022 and is designated Class II. Reason for recall: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. The recall status is ongoing. Affected quantity: 828 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 828 kits
Product Description
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Reason for Recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Distribution Pattern
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Code Information
Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0561-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026