Device product
DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
Z-0569-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 918 kits
- Official record key
device-enforcement:Z-0569-2023
Official wording
Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Code information: Lot Numbers: Lot 56005273 exp 5/1/2024; Lot 56657845 exp 5/1/2024; Lot 57021523 exp 8/1/2024; Lot 57392244 exp 8/1/2024; Lot 57770575 exp 3/1/2025
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.