Device product
DeRoyal CATARACT PACK CSM, REF 89-6863
Z-0580-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1220 kits
- Official record key
device-enforcement:Z-0580-2023
Official wording
Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Code information: Lot Numbers: Lot 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***
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.