Device product
DeRoyal CATARACT PACK, REF 89-10086.05
Z-0715-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 520 kits
- Official record key
device-enforcement:Z-0715-2023
Official wording
Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Code information: Lot Numbers: 57003552 exp 09/01/2024; 57467226 exp 12/01/2024; 55748075 exp *; 56250244 exp *; 57899344 exp *; 57913353 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.