Device product
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Z-0102-2023
Product summary
- Event
- Event 90871
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 devices
- Official record key
device-enforcement:Z-0102-2023
Official wording
Reason: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
Code information: UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
Distribution pattern: US Nationwide distribution in the state of Florida.
Derived failure modes
-
Labeling or packaging
Mislabeling