Device product
DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
Z-0573-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 144 kits
- Official record key
device-enforcement:Z-0573-2023
Official wording
Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Code information: Lot Numbers: Lot 56391741 exp 1/1/2023; Lot 56617587 exp 2/1/2025; Lot 57391604 exp 1/1/2024
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.