Device product
MEDLINE HEART CABG CDS, REF CDS983376R
Z-0119-2025
Product summary
- Event
- Event 95393
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-0119-2025
Official wording
Reason: Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Code information: UDI/DI 40195327548545 (case), 10195327548544 (each), Lot Numbers: 24BMF012, 24CMG491
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
incorrectly labeled