Device product
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Z-1048-2025
Product summary
- Event
- Event 96066
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1200 units
- Official record key
device-enforcement:Z-1048-2025
Official wording
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Code information: UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990
Distribution pattern: US: FL, KS, ND, PA, WA, WV, IL, WA
Derived failure modes
-
Labeling or packaging
mislabeled