Device product
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Z-0561-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 828 kits
- Official record key
device-enforcement:Z-0561-2023
Official wording
Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
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
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
Derived failure modes
-
Unknown
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.