Z-1048-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 units
Product Description
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Reason for Recall
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Distribution Pattern
US: FL, KS, ND, PA, WA, WV, IL, WA
Code Information
UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990